AVP, Scrum Master

Customer Service Specialist

Scientist I, Quality Control LTS

Operator III, Packaging - 2nd Shift

Dry Etch Principal Engineer/ MTS Lead, Process Development, Advance NAND

Electrical Engineer – Industrial Power

Mechanical Engineer

Procurement Specialist

Site Quality Leader

EHS Analyst

Responsibilities: <ul><li>Lead and Manage the delivery activities of multiple scrum teams in a manner that aligns with automation strategy set by business counterparts</li><li>Anchor and effectively apply the Agile Manifesto, SAFe core values, Lean-Agile mindset and SAFe principles to lead multiple high-performing, cross-functional agile scrum/Kanban teams as the Scrum Master</li><li>Work with business teams to shape business requirements and provide ongoing communication through project execution.</li><li>Ensures development stories, acceptance criteria, assumptions, and all related documentation are timely and complete, supporting development, testing, and user acceptance activities.</li><li>Assisting product owner to create roadmaps and their dissemination to the team(s), while leading, managing, tracking, and communicating the execution of the plans and ensure that projects are completed on time.</li><li>Communicate and facilitate effectively across diverse audiences within and outside of the Sprint Team (key stakeholders, executives).</li><li>Work with cross-functional teams (not limited to - architects, application engineers, UX designers, and outsourced vendors) to create a holistic roadmap and planning for product delivery</li><li>Well versed in all Scrum/SAFe ceremonies: Daily Standups, Backlog maintenance and Grooming, Sprint Planning and Review, Release Planning, Demos &amp; Retrospectives, Scrum-of-Scrums, Inspect and Adapt event, and PI Planning.</li><li>Manage Sprints - keeping order, process, delivery, priorities accurate and on time Keep scrum team focused on concrete priorities while keeping outside influences from disrupting the Scrum team and actively identify and remove waste and distractions</li><li>Work with Product Owners and QA team to ensure that testing and feedback is completed in a timely manner and meeting the Sprint timelines.</li><li>Advocate for autonomous, self-organizing, empowered, and continuously improving teams. Continuously strives to coach team and product owner to deliver higher customer satisfaction, improved velocity and delivery predictability, better</li><li>system performance and enhanced ability to innovate, scale, and meet compliance requirements.</li><li>Lead in production support prioritization with key stakeholders and identify and pursue improvements.</li><li>Facilitate regular meetings with all relevant stakeholders and project team to discuss/share status and to track progress &amp; health of the project.</li><li>Perform other duties and/or special projects as assigned</li></ul> Requirements: <ul><li>Bachelors Degree in any discipline with minimum 8+ years of overall experience or in lieu of a degree, 10+ years of overall experience.</li><li>Minimum of 5 years of experience in developing and implementing information systems</li><li>CSM/SAFe Certified is a must.</li><li>Experience in People/ Vendor management</li><li>Ability to build &amp; maintain relationships &amp; partnerships with key stakeholders.</li><li>Excellent knowledge on Agile methodologies and practices</li><li>Excellent verbal, written, and communication skills. Should be able to communicate effectively to varied audiences changing style and format depending on stakeholder needs.</li><li>Proven leadership and effective decision-making capabilities</li><li>Demonstrated experience in conflict resolution</li><li>Ability to monitor and manage critical path elements of consolidated projects &amp; programs Contact Center Technology project management experience</li></ul>

Responsibilities: Quote and Order Management: <ul><li>Interface with Customers for Quote request or Price inquiries and approval</li><li>Submit quotation request for pricing team approval.&nbsp;</li><li>Sales order entry, order confirmation &amp; expediting orders.</li><li>Order change and backlog price adjustment</li><li>On-going Backlog Management</li><li>Shipment release and follow up</li><li>Report and support past due backlog reduction</li><li>NPI - follow up with PM/Plant/Finance for part master and cost setup</li><li>Handle Sample order</li><li>Process RMA / Goods replacement</li></ul> Customer Service: <ul><li>Handle customer enquiries &amp; complaints. Investigate and work with other departments to resolve customer issues in a timely manner.&nbsp;</li><li>Emails/Conference calls / Customer and company Plant Visits for critical delivery issues, expedition or projects.&nbsp;</li><li>Work out solutions on Customer’s special requirements, such as label, Customs process, packing &amp; etc.&nbsp;</li><li>NPS/VOC/Customer Service Survey Improvement Process. Identify and work on corrective actions to recurring issues.&nbsp;</li></ul> Customer Supply Chain Management: <ul><li>Initiate Stock Requisition for customer advance order or buffer stock.</li><li>Work with Planning team on capacity adjustment in order to fulfill Customer’s demands</li><li>Consignment Stock Management/ Customer demand forecast monitoring and accuracy analysis</li><li>Manage customer forecast/demand and inventory level, work with Supply Chain to fulfill customer demand.&nbsp;</li><li>Negotiate with Customer for VMI liability and deadstock compensation.</li><li>Resolve logistics and custom issues with relevant functions</li></ul> Customer Credit and Billing Management: <ul><li>Billing attainment</li><li>Follow up queries with Account Receivable</li><li>Coordinate with Finance and Customer to solve pass due invoices issue</li><li>Manage customer credit status &amp; escalate for any abnormal status</li><li>Apply credit release</li><li>Process Credit note / Debit Note</li></ul> Requirements: <ul><li>Bachelor’s degree or equivalent</li><li>2–3+ years in customer service / order management (manufacturing preferred)</li><li>Strong communication and stakeholder management skills</li><li>Experience handling customer complaints and resolution</li><li>Ability to work under pressure in a fast-paced environment</li><li>Proactive mindset with strong ownership and accountability</li><li>SAP knowledge preferred</li><li>Mandarin communication capability is a plus</li></ul>

Role Description: <ul><li>The Scientist, Laboratory Technical Services is primarily responsible for supporting the analytical testing requirements of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial testing of materials and samples in a regulated laboratory environment. </li><li>Has expert proficiency in conducting all types of physical and chemical analysis (including the most complex analysis) using all equipment. </li><li>This position will have a significant role supporting pending ANDA submissions, product launches, and method lifecycle activities to achieve company goals and initiatives. Write and review SOPs, test methods, validation protocols and reports. The Scientist also provides mentoring to Chemist.</li></ul> Responisbilities: Analysis &amp; Testing: <ul><li>Validate analytical methods for finished product and raw material release and stability testing.</li><li>Evaluates, troubleshoot/improves existing analytical methods when necessary.</li><li>Prepares method validation protocols, reports, and analytical test methods.</li><li>Performs testing to support process and formulation development (e.g. excipient, compatibility, solubility, dissolution studies, stability/impurity assessment)</li><li>Performs work to support project assigned with little oversight.</li><li>Presents analytical data to project team for review and discussion</li><li>Reviews and approves laboratory test data and documentation (e.g. notebooks, raw data and technical documentation, test methods, validation protocols, or validation report) for completeness and compliance when necessary</li><li>Reviews and evaluates drug substance supplier’s technical documents to ensure internal testing test requirements are adequate.</li><li>Uses laboratory software for analysis.</li><li>Is alert to and detects abnormalities during performances of test and reviews.</li></ul> Lab Equipment: <ul><li>Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping.</li><li>Cleans lab working surfaces and dispose of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals</li><li>Troubleshoots instrumentation and performs subsequent analyses</li></ul> Investigations: <ul><li>Evaluates questionable sample results, OOS, and aberrant results immediately to Supervisor and recommends a course of action related to LTS activities</li><li>Participates in root cause identification of complex laboratory investigations.</li><li>Writes, edits, and reviews SOPs and laboratory investigations</li></ul> Training: <ul><li>Train junior Scientist/Chemists on analytical techniques.</li><li>Continuously updates knowledge with respect to the latest technologies related to analytical science</li><li>Maintains assigned training records current and in-compliance</li><li>Actively assumes/demonstrates responsibility in training others in good documentation practice, practical lab skills, and chemical theories, methodologies and procedures</li></ul> Compliance: <ul><li>Identifies need for SOPs and writes or revises, as appropriate</li><li>Performs work in a timely and safe manner conforming to regulatory, company and compendial requirements within pharmaceutical manufacturing setting. Works in compliance with cGMP/cGLP regulations</li><li>Documents data generated in notebooks/worksheets/LIMS in compliance with SOPs</li><li>Takes active role in auditing laboratory logbooks/documentation to ensure compliance</li><li>Follows internal processes related to controlled substances</li></ul> Safety: <ul><li>Follows EH&amp;S procedures to ensure a safe work environment</li><li>Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS</li></ul> Requirements: Education &amp; Experience: <ul><li>Bachelor of Science Degree in chemistry, chemical engineering or related field with 6 years’ relevant analytical laboratory experience OR</li><li>Master’s degree in above disciplines with 4 years’ relevant analytical lab experience OR</li><li>PhD in above disciplines with some relevant analytical laboratory experience preferred</li></ul> Knowledge &amp; Skills: <ul><li>Has strong knowledge of laboratory software and has expanded knowledge of chromatographic software (e.g. Waters Empower, Agilent ChemStation and Sotax WinSotax), using custom fields, custom calculations and custom reports.</li><li>Full proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc.</li><li>Thorough knowledge of applicable safety and standards guidelines, such as FDA, ICH, SOP, cGMP, GLP, DEA regulations and/or MSDS</li><li>Has demonstrated competence in conducting chemical analyses</li><li>Strong knowledge of wet chemistry techniques</li><li>Competency in Microsoft Office Suite</li><li>Ability to critically review, analyze data, interpret information, and draw conclusions from relevant or missing information</li><li>Ability to display and analyze data in a logical manner</li><li>Strong verbal and written communication skills as well as good computer skills</li><li>Strong attention to details and accurate record keeping</li><li>Establish and maintain cooperative working relationships with others.</li><li>Solid organizational skills</li><li>Ability to coach less senior staff and develop laboratory skills and ability</li><li>Ability to take initiative, set priorities and follow through on assignments</li></ul> Physical Requirements: <ul><li>Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals</li><li>Must occasionally lift and/or move up to 15-25 lbs.</li><li>Ability to wear personal protective equipment, including respirators, gloves, etc.</li><li>Specific visions abilities are required by this job include close vision and color vision</li><li>Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods.</li></ul>

Role Description: <ul><li>With thorough knowledge and skills in all areas of the packaging process, performs more advanced functions relating to the packaging of drug products consistent with established Current Good Manufacturing Practices (cGMP), customer requirements and in conjunction with all Standard Operating Procedures (SOP). Is qualified in both Filling and Labeling. </li><li>Is qualified and capable of competently running all packaging equipment across the entire packaging department. </li><li>Responsible for the safe and efficient execution of their job duties, while ensuring product compliance to established standards. May serve as back-up to the Senior Packaging Technician.</li></ul> Responsibilities: Packaging Operations: <ul><li>Is qualified and capable of competently running all packaging equipment across the entire packaging department</li><li>Is qualified in both Filling and Labeling</li><li>Ensures that all equipment is running properly</li><li>Executes processes such as material handling, capping, outserts/med guides, in-process checks, packing, stacking, cartooning, etc.</li><li>May request components, labels and inserts per the BPR</li><li>Sets up packaging machinery; accurately sets equipment programming according to BPRs and SOPs</li><li>Sets up, starts, operates, adjusts, troubleshoots and tears down packaging lines</li><li>Executes Batch Production Record (BPR) and logbook documentation with detail and accuracy</li><li>Accurately reviews BPRs steps for completeness and accuracy</li><li>Collects samples from each batch and submits to QA for retained samples</li><li>Demonstrates the ability to execute procedures and complete tasks in a compliant and safe manner</li></ul> Equipment Cleaning: <ul><li>Conducts verification of line/equipment cleaning and documents per SOP</li><li>Executes the procedures used to clean pharmaceutical packaging equipment and facilities</li><li>Conducts Master Cleans and Surface Cleans</li></ul> Continuous Improvement : <ul><li>Identifies 6S opportunities and sustains the 6S process</li><li>Assists in troubleshooting process issues</li></ul> Issues and Deviations: <ul><li>Identifies and reports processing related issues to Packaging Supervisor and to Quality personnel.</li></ul> Quality: <ul><li>Executes the required in-process product quality checks and documents accurately.</li></ul> Teamwork and Collaboration: <ul><li>Demonstrates the ability to work in collaboration with others as a part of a team.</li></ul> Training: <ul><li>Stays current on SOPs and cGMPs.</li><li>May participate in training qualifier classes.</li></ul> Safety and Compliance: <ul><li>Participate in safety teams, start-up discussions, incident debriefs, etc.</li><li>Carries out processing/packaging activities safely, as required, on a daily basis.</li><li>Follows all safety and compliance procedures and participates in required training.</li><li>Adheres to all cGMP compliance/regulatory mandates and quality requirements.</li><li>Ensures compliance with SOPs, Policies and Procedures as required by Par and regulatory agencies</li></ul> Misc.: <ul><li>Other related duties as assigned to meet departmental and Company objectives.</li></ul> Requirements: Education &amp; Experience: <ul><li>High school diploma or equivalent.</li><li>3 years of packaging experience</li></ul> Knowledge &amp; Skills: <ul><li>Knowledge of cGMP regulations and processes.</li><li>Qualified in both Filling and Labeling</li><li>Qualified and capable of setting up and running all machinery in the value stream</li><li>Competent in Master Clean/Surface Clean</li><li>Ability to sample batches</li><li>Ability to follow both verbal and written instructions including SOP’s and Batch Record documentation</li><li>Ability to accurately and precisely record data and batch information</li><li>Ability to work in both independent and team environments</li><li>May become a certified trainer and provide certified training in one process</li><li>Effectively interfaces with other department personnel if Senior level (4th level) isn’t available</li><li>Ability to troubleshoot process issues</li><li>Ability to Identify 6S opportunities and sustain the 6S process</li><li>Ability to participate in Continuous Improvement projects</li><li>Proficient in reading and writing English to understand work instructions and document results</li></ul> Physical Requirements: <ul><li>Must be able to stand for long periods of time (8- or 12-hour shifts), lift at least 35 pounds, climb ladders, wear a dust mask or respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.</li><li>Dexterity - ability to quickly move your hand, your hand together with your arm, or your two hands to grasp, manipulate, or assemble objects.</li><li>Vision - ability to see details at close range (within a few feet of the observer).</li><li>Multi-limb Coordination - ability to coordinate two or more limbs (for example, two arms, two legs, or one leg and one arm) while sitting or standing.</li></ul>

Responsibilities: Program and Project Management <ul><li>Manage efforts and set the strategy for developing process technology for assigned products in Process R&amp;D.</li><li>Offer routine project coordination and technical support to your process development team.</li><li>Handle the demands of several customers to determine priorities for your team.</li><li>Resolve yield and defect issues related to your process area.</li><li>Collaborate with the Manufacturing Development Engineering team to meet R&amp;D product quality and cycle time goals.</li><li>Work with R&amp;D Management, Process Integration, and High-Volume Manufacturing Sites to regularly align on project requirements, priorities, and timelines.</li><li>Engage manufacturing sites, Manufacturing Integration, and Central Teams to provide technical direction and maintain alignment between production and R&amp;D.</li><li>Drive ongoing process and operational efficiency improvements to meet the needs of PI and manufacturing by actively interacting with the equipment development team and suppliers.</li><li>Interact with equipment and chemical vendors to ensure alignment and timely progress on our roadmaps, as well as foster a positive relationship.</li></ul> Performance Management <ul><li>Partner with direct reports to develop long/short-term goals and projects that meet the needs of the Technology Development department.</li><li>Offer ongoing feedback to your team members on performance, establishing a career plan and mentoring your team members to encourage their professional development.</li><li>Set and communicate performance goals for the team, and lead goal-based performance evaluations for all team members.</li><li>Mentor team members on technical as well as soft skills (presentation skills, risk management, decision making, vendor interaction, etc.)</li><li>Recognize and reward company team members for outstanding performance.</li><li>Recruit both external and internal candidates to fill headcount in the group.</li><li>Provide conflict resolution if issues arise.</li></ul> Requirements: <ul><li>PhD or Masters in Physics, Electrical Engineering, Mechanical Engineering, Materials Science, Chemical Engineering, along with at least 8 years of experience in the semiconductor industry concentrating on dry etch technology and managing personnel.</li><li>Bachelors degree in Physics, Electrical Engineering, Mechanical Engineering, Materials Science, Chemical Engineering, along with at least 15 years of experience in the semiconductor sector concentrating on Dry Etch technology and managing personnel.</li><li>At least five years of experience leading a process development team in a semiconductor R&amp;D or high-volume manufacturing environment.</li><li>Comprehensive understanding of Plasma Dry Etch Technology.</li><li>Knowledge and experience in high aspect ratio etch development.</li><li>Demonstration of collaborative ways of problem solving.</li><li>Understand hard mask requirements based on material properties.</li><li>Positive relationship building skills, both with internal and external customers.</li><li>Demonstrated structured problem-solving capabilities.</li><li>Strong communication and interpersonal skills (written, verbal, and presentation).</li><li>Experience in being a mentor to manage the performance of direct reports.</li><li>Ability to seek opportunities for continuous improvement, as a team member, leader, and for the organization.</li></ul>

Responsibilities: <ul><li>Develop and execute complex projects that have a substantial mix of electrical, mechanical, physics, algorithms and software design; attend design reviews and provide input to meet market requirement specifications (MRS) and hardware/software specifications.</li><li>Ensure designs meet market requirement specifications (MRS). Coordinate with project marketing and management to understand system requirements.</li><li>Be able to chair architecture brainstorming meetings and drive the systems process to down select to a final architecture of a top-level system.</li><li>Participate in the design, development, and testing of radio-frequency components for semiconductor equipment, which includes high-power generators (up to 6 kW or more), matching networks, filters, or other tuning elements, with frequencies ranging from 300 kHz to 60 MHz.</li><li>Write detailed specifications that cover all aspects of subsystem modules including interfaces to the product by using systems analysis to create a diagram. </li><li>Create concepts for complex architectural design approaches. Lead team evaluations of architectures to provide recommendation for best system solution approach.</li><li>Fabricate or modify RF components to change their performance or enable access for instrumentation.</li><li>Instrument, characterize and troubleshoot RF sub-systems within larger semiconductor tool environment.</li><li>Problem identification and troubleshooting a wide range of difficult, complex engineering problems in field of technical expertise, including serviceability and manufacturability.</li><li>Support System Integration during the assembly and final testing of new product designs.</li><li>Interface with other groups to workout design, systems architecture development and integration issues.</li><li>Define all equipment interfaces and systems architecture and ensure they are up to date and documented.</li><li>Work with vendors to develop design requirements and ensure delivery of parts that meet specifications.</li></ul> Requirements: <ul><li>PhD/ Master/ Bachelor’s degree in Electrical or Mechanical Engineering with few years of relevant RF experiences</li><li>Understand principles and operation of network analyzers, oscilloscopes, power meters, directional couplers, and other radio-frequency test equipment</li><li>Knowledge of circuit theory and ability to develop analytical models of RF components</li><li>Problem-solving and troubleshooting skills</li><li>Excellent verbal and written communication skills and the ability to interact professionally with a diverse group of internal and external stakeholders</li><li>Self-starting individual, proactive and resourceful</li></ul>

Responsibilities: <ul><li>In support of design projects, coordinate the procurement and assembly of mechanical components/equipment and identify sources of critical parts and subsystems to resolve basic technical issues</li><li>Design or modify mechanical engineering layouts/schematics, and/or detailed drawings/specifications of limited scope under direct supervision</li><li>Perform and document engineering test reports under direct supervision</li><li>Generate related alpha/gamma documentation for product release under direct supervision</li><li>Perform engineering analysis under direct supervision</li><li>Troubleshoots a variety of mechanical problems of general difficulty under direct supervision</li><li>Effective use of engineering processes in the resolution of basic mechanical problems of limited scope</li><li>May be responsible for the design, development and implementation of custom mechanical tooling, fixturing, and associated processes to enable the handling, assembly and/or disassembly of parts, components, sub-assemblies and final assemblies throughout the product life cycle</li><li>Work with suppliers to ensure parts can be manufactured in accordance with performance and cost objectives.</li><li>Perform 3D modelling</li></ul> Requirements: <ul><li>Master Degree in Mechanical Engineering</li><li>Basic knowledge or experiences in semiconductor industry</li><li>Prior 3D modelling experiences will be an added advantage</li><li>Skilled in Unigraphics - NX</li></ul>

Role Description: <ul><li>The Procurement Specialist is responsible for managing the procurement of direct and indirect materials and services to ensure uninterrupted supply to manufacturing operations while achieving cost, quality, delivery, and working capital objectives. </li><li>The role partners closely with Production Planning, Operations, Quality, Finance, and Global Procurement to execute sourcing strategies, manage supplier performance, and support continuous improvement initiatives across the supply chain.&nbsp;</li><li>The successful candidate will have strong procurement execution skills, supplier management experience, and a proactive approach to resolving supply risks and driving operational excellence.&nbsp;</li></ul> Responsibilities: Procurement &amp; Supply Management&nbsp; <ul><li>Execute procurement activities for assigned direct materials, packaging materials, indirect spend categories, and services.</li><li>Convert purchase requisitions into purchase orders and manage end-to-end procurement transactions within SAP.</li><li>Ensure material availability to support production plans and customer commitments.</li><li>Monitor supplier delivery performance and proactively manage supply risks.</li><li>Coordinate with planning and operations teams to address shortages, delays, and capacity constraints.</li><li>Maintain optimal inventory levels in line with working capital and service objectives.&nbsp;</li></ul> Supplier Management&nbsp; <ul><li>Manage day-to-day supplier relationships and performance.</li><li>Monitor supplier KPIs including:&nbsp;&nbsp;On-Time Delivery (OTD), Quality performance, Lead time adherence, Responsiveness&nbsp;, Cost competitiveness</li><li>Conduct supplier performance reviews and support corrective action implementation where required.&nbsp;</li><li>Escalate supply risks and develop mitigation plans to ensure business continuity.</li></ul> Cost &amp; Contract Management <ul><li>Support sourcing initiatives and cost reduction projects.</li><li>Obtain quotations and conduct commercial evaluations.</li><li>Participate in supplier negotiations under guidance from Global Procurement or Supply Chain leadership.</li><li>Support implementation of payment term optimization initiatives.</li><li>Ensure contract pricing and procurement terms are accurately maintained within systems.&nbsp;&nbsp;</li></ul> Inventory &amp; Working Capital Management&nbsp; <ul><li>Collaborate with planning teams to optimize inventory levels.</li><li>Identify excess, obsolete, and slow-moving inventory risks.</li><li>Support inventory reduction initiatives without compromising customer service.</li><li>Monitor supplier lead times and MOQ impacts on inventory performance.</li></ul> SAP &amp; Process Excellence&nbsp; <ul><li>Maintain accurate procurement master data including:&nbsp;&nbsp;Vendor records, Pricing information, Lead times, Procurement parameters&nbsp;</li><li>Support SAP implementation and continuous process standardization initiatives.</li><li>Ensure compliance with procurement policies, approval authorities, and audit requirements.</li><li>Drive continuous improvement opportunities in procurement processes and supplier collaboration.</li></ul> Requirements:&nbsp; <ul><li>Bachelors Degree in Supply Chain Management, Procurement, Business Administration, Engineering, or related discipline.</li><li>3–7 years of procurement, purchasing, materials management, or supply chain experience.</li><li>Experience in manufacturing environments preferred.</li><li>Experience working with international suppliers and supply networks.</li><li>SAP ERP experience preferred.</li><li>Experience supporting sourcing, supplier management, and inventory optimization initiatives.</li><li>Experience in procurement or supply chain within a manufacturing environment.</li><li>Good understanding of supplier management, inventory control, and material planning (MRP).</li><li>Proficiency in SAP and Microsoft Excel for procurement and data analysis.</li><li>Strong communication, negotiation, and problem-solving skills.</li><li>Ability to collaborate effectively with cross-functional teams and suppliers.</li><li>Experience supporting cost-saving, process improvement, or SAP implementation initiatives.&nbsp;&nbsp;</li></ul>&nbsp;&nbsp;

Role Description: <ul><li>The Site Quality Leader is responsible for the administration, supervision, and development of the Wilsonville Quality Assurance and Quality Engineering functions.&nbsp;</li><li>This position is responsible for ensuring full compliance to the regulatory requirements of 21 CFR 820, ISO13485, MDR and other applicable regulations including production and process controls.&nbsp;</li><li>The Site Quality Leader will report to the Global Head of Quality Operations.</li></ul> Responsibilities: <ul><li>Ensure that Material Review Boards are in place to ensure products are appropriately dispositioned within a timely manner, while ensuring appropriate corrective and preventive actions are initiated and regulatory requirements are met.</li></ul>&nbsp;Develop and implement systems to assure that development as well as production teams receive support in the following areas: <ul><li>Quality planning, including inspection techniques and sampling methods</li><li>Statistical Analysis</li><li>Application of required regulatory standards</li></ul> Develop and implement procedures and systems to assure product manufactured for human use meets design and functional specifications. These systems are to include as a minimum: <ul><li>Delivery of raw materials and components</li><li>Manufactured devices and equipment</li><li>Documentation associated with these functions</li><li>Develop, track, and report on the following administrative systems:</li><li>Department metrics</li><li>Department objectives</li><li>Personnel development and training</li><li>Support regulatory agency and customer quality audits.</li><li>Ensure the conformity of the components and products are appropriately checked in accordance with the Quality Management System before release.</li><li>Responsible for assisting and training associates in concepts of probability and statistics.</li><li>Responsible for failure appraisal and analysis (internal and external).</li><li>Authority to place products or processes on hold.</li><li>Design and develop forms and instructions for recording, evaluating, and reporting quality data.</li><li>Corrective and Preventive Action program</li><li>Based on operational/quality requirements, assist in test equipment selection and validation.</li><li>Utilize formal problem solving techniques to resolve product and/or process related issues.</li><li>As required, lead cross-functional teams to support resolution of product and/or process related issues or objectives.</li><li>Work with suppliers of both raw materials and components, to improve product quality and/or resolve quality issues.</li><li>Be innovative, knowledgeable and intensely committed to ensure that every product and service we supply conforms to FDA and Quality System Regulations..</li></ul> Requirements: <ul><li>Bachelors Degree with a scientific or engineering emphasis.</li><li>ASQ Certified Quality Engineer recommended. Six Sigma Green/Black belt recommended.</li><li>7-10 years experience in a related regulatory environment.</li><li>Experience should include positions at senior levels within the medical device organizations.</li></ul>

Responsibilities: Planning; <ul><li>Initiate annual EHS training plan &amp; EHS internal audit plan in order to meet the department annual operating plan.</li></ul> Procedures &amp; Document Update; <ul><li>Review &amp; update EHS procedure according to internal &amp; external audit finding.</li><li>Initiate, update and execute EHS policies or procedures according to national laws and regulations or S.A.F.E or Global policies in order to fulfill company EHS system and make work efficient.</li></ul> Safety and Health Management: <ul><li>Submit application to Safety Bureau for Safety and Health Impact Assessment and other required permits or registration in order to meet the requirement of national laws and regulations.</li><li>Conduct Safety Standard Management review and follow in velocity EHS system.</li><li>Coordinate industrial hygiene monitoring, evaluation, medical surveillance in order to prevent occupational disease.</li><li>Maintain SAFE and environment tool with continuous improvement.</li><li>Follow up Incident investigation, correction and Injury Trend Analysis in order to prevent incidents.</li><li>Conduct canteen and dormitory inspection with Admin. to supervise food safety and fire safety,in order to prevent incidents.</li><li>Conduct contractor &amp; supplier EHS management, issuing non-routine high risk task permits, in order to prevent incidents.</li></ul> EHS Projects: <ul><li>Lead and follow up JSA, LOTO, Ergo, Machine Guarding,BBS, Nearhit reporting, PPE management, IH, Environmental and etc.</li><li>Coordinate the Kaizens and other EHS activities, in order to meet SAFE and 5 star requirement and prevent incidents.</li></ul> Audit; <ul><li>Implement routine EHS internal audit and examine;</li><li>Prepare necessary material or data sheet for S.A.F.E ,customer, local government, global audit;in order to ensure meet compliance requirements.</li></ul> Reporting &amp; Training: <ul><li>Prepare Monthly EHS performance report in order to present EHS performance;</li><li>Organize health and safety related training to employee in order to promote the awareness of health and safety."</li></ul> Requirements: <ul><li>Minimum 5+ years of EH&amp;S experience required;</li><li>Possesses a strong grasp of Malaysias EHS laws and regulations, EHS Greenbook,can conduct compliance assessments.</li><li>Autonomous ability in conducting audits and inspections of all aspects of EHS;</li><li>Good reading and writing in English &amp; Chinese</li><li>Skilled in leveraging Excel for data analysis, visualization, and tracking key metrics.</li></ul>

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87 material master Jobs found

AVP, Scrum Master

Customer Service Specialist

Scientist I, Quality Control LTS

Operator III, Packaging - 2nd Shift

Dry Etch Principal Engineer/ MTS Lead, Process Development, Advance NAND

Electrical Engineer – Industrial Power

Mechanical Engineer

Procurement Specialist

Site Quality Leader

EHS Analyst

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Skills

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87 material master Jobs found

AVP, Scrum Master

Customer Service Specialist

Scientist I, Quality Control LTS

Operator III, Packaging - 2nd Shift

Dry Etch Principal Engineer/ MTS Lead, Process Development, Advance NAND

Electrical Engineer – Industrial Power

Mechanical Engineer

Procurement Specialist

Site Quality Leader

EHS Analyst

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WhiteCrow is on a mission to connect companies with the best talent across the globe.