Scientist I, Quality Control LTS

Principal/Staff, Firmware and Product Test (SSD)

Process Technician

Mechanical Engineer

Manager, UAT Analyst - Retail Operational Readiness Centre

Procurement Specialist

Supply Planning & Order Management Sr Specialist

Manufacturing Engineer

Process Engineering Manager

Site Quality Leader

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>

Responsibilities: <ul><li>Build comprehensive firmware verification plans for various firmware features.</li><li>Develop white/ grey-box, known, and closed system testing methods to verify and validate firmware products.</li><li>Analyze failures from weekly regressions and perform root-cause analysis, requiring deep SSD domain expertise.</li><li>Manage test development, test deployment, test automation, and reporting activities.</li><li>Communicate challenges, solutions, and mitigation plans to cross-functional teams and management with clear and effective communication of both technical and non-technical topics.</li><li>Participate in code reviews and guide the team to ensure comprehensive coverage and accurate architectural build.</li><li>Establish strong working relationships with firmware development engineers to improve code quality.</li><li>Lead a team of technical people, as required.</li></ul>&nbsp;Requirements: <ul><li>B.Sc. in Electrical Engineering, Computer Engineering, or Computer Science</li><li>6-8 years of pertinent experience in SSD firmware test development</li><li>Comprehensive understanding and substantial experience in SSD firmware testing and Python programming</li><li>Deep understanding of storage industry protocols such as PCIe, NVMe and NVMe-MI, with ability to design and develop tests aligned with specifications.</li><li>Familiarity with Agile/ Scrum development, GIT-based development workflow and branch management.</li><li>Experience with automated build, continuous integration, and test automation systems</li><li>Highly organized, creative, motivated, and passionate about achieving results</li><li>Ability to work on complex tasks independently with minimal supervision</li><li>Demonstrated leadership abilities and the capability to mentor less experienced engineers</li><li>Excellent problem-solving and analytical skills</li><li>Strong interpersonal and communication skills, and a great teammate</li></ul>

Responsibilities: <ul><li>Assisting engineer to work on developing process technology for advanced CVD / PVD processes</li><li>Responsible for performing basic recipe and CH troubleshooting during process runs and implement changes based on directions from the engineer&nbsp;&nbsp;</li><li>Owner for the execution of module process, data collection for measurement &amp; inspection and sharing of data with the engineer</li><li>Interact with internal and external CH and metrology tool owners to align for tool time, execute process sequence and collect data to feedback to engineer</li><li>Occasional over-time to support process engineering support activities</li></ul> Requirements: <ul><li>Ability to work on rotational day, afternoon or night/ overnight shift</li><li>Basic understanding on semiconductor process is preferred</li><li>Candidates with prior semiconductor equipment experiences can be considered</li><li>Prior experience in Process Technology as technician in Fab/Cleanroom area (CVD, PVD, ALD etc.) will be added advantage</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>Bachelor 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>

Responsibilities: <ul><li>Understand Business Requirements and Functional Specs/ User Story documents</li><li>Prepare Test Case Design using TOSCA or other Bank approved tools for the technology change</li><li>Ensure traceability for requirements/ functional specs to test cases</li><li>Engage business/ operations users to review test cases and incorporate their feedback into test pack</li><li>Identify potential scenarios for Test Automation working with the Automation Lead</li><li>Drive Manual &amp; Automated Test Execution (using TOSCA/ other Bank Approved tool) as per the UAT Plan in line with the test strategy and test plan</li><li>Ensure all test scope and test cases are executed and fulfil the specified requirements within the agreed timeline</li><li>Report defects discovered in UAT, attend defect calls and participate in defect management process and retest</li><li>Review UAT test results and publish test metrics</li><li>Perform Exploratory Test Case execution</li><li>Provide operational readiness support and conduct training on new system/ enhancement to impacted operations and/ or business users</li><li>Provide post-implementation support to operations users</li><li>Review and submit management reports as required by the Bank’s Software Development Framework</li></ul> Requirements: <ul><li>Bachelor’s degree</li><li>Minimum 4 years of experience preferably in financial institutions</li><li>Well-versed in operations especially Swift standard in either AS400 / Mainframe applications, Internet / Mobile Banking Application, Cards and Channels application will be an added advantage</li><li>Have a good knowledge and experience in handling testing or test management life cycle</li><li>Proficient computer skills</li><li>Strong analytical skills</li><li>Strong verbal and written communications skills, including effective presentation skills</li><li>Able to take ownership of issues and take them to closure</li><li>Able to create effective work relationships across different levels of stakeholders from various disciplines</li><li>Experience in managing team</li><li>Motivated driven and can work under pressure and able to complete task given within the project timeline</li><li>Mature individual with strong leadership, influencing and problem resolution skills</li><li>Lead human resource planning, development and staff management</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;

Responsibilities: Order Management &amp; Fulfilment Execution <ul><li>Manage end-to-end order intake to fulfilment process ensuring alignment with customer requirements and supply capabilities.</li><li>Monitor and manage order backlog, ensuring timely resolution of constraints and prioritization.</li><li>Coordinate closely with Customer Support / Commercial teams on demand fulfilment and order commitments.</li><li>Drive proactive communication on order status, delays, and recovery plans.</li></ul> Supply Planning &amp; Prioritization <ul><li>Collaborate with Production Planners to translate demand into executable production and fulfilment plans.</li><li>Lead order prioritization decisions based on customer criticality, contractual commitments, and business impact.</li><li>Ensure optimal allocation of constrained supply across customers and regions.</li><li>Support escalation management for supply-demand imbalances.</li></ul> Capacity Planning &amp; RCCP <ul><li>Develop and maintain Rough-Cut Capacity Planning (RCCP) to ensure alignment between demand and production capacity.</li><li>Identify capacity constraints early and drive mitigation actions (e.g., alternate sourcing, schedule optimization, subcontracting).</li><li>Partner with manufacturing and procurement teams to balance load vs. capacity.</li></ul> Customer Stock Build &amp; Inventory Coordination <ul><li>Manage customer-specific stock build strategies to support service level targets and campaign demand.</li><li>Coordinate with inventory and warehouse teams to ensure optimal stock positioning Monitor and control inventory risks (excess, slow-moving, or shortages) linked to customer demand patterns.</li></ul> Cross-Functional Coordination (Control Tower Role) Act as the central coordination point between: <ul><li>Commercial / Demand Planning.</li><li>Customer Service o Production Planning.</li><li>Procurement / Logistics o Global Supply Chain team.</li><li>Drive alignment on order fulfilment strategies and execution plans.</li><li>Lead regular order fulfilment reviews and backlog governance meetings.</li><li>Performance Monitoring &amp; Continuous Improvement.</li></ul> Track and report key KPIs: <ul><li>OTIF (On-Time In-Full).</li><li>Backlog aging.</li><li>Service level adherence.</li><li>Capacity utilization.</li></ul> Identify root causes of service failures and drive corrective actions Lead or support initiatives to improve: <ul><li>Order cycle time.</li><li>Planning accuracy.</li><li>Supply chain responsiveness.</li></ul> Requirements: <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.&nbsp;</li></ul>

Responsibilities: <ul><li>Responsible for various KPI’s pertaining manufacturing engineering and Team Management skills is must.</li><li>Responsible for assembly Process, Tool Design development, (New &amp; Old tools) Qualification and Trial</li><li>Improves manufacturing efficiency by analyzing planning workflow, space requirements, and equipment layout</li><li>Work with Global COE Assembly to drive continuous improvement in Assembly Technology / Process</li><li>Maintain proper documentation and for all assembly tooling, Spares and Process Set-up&nbsp;</li><li>Ensure all Tooling / automation design drawings (Soft &amp; Hard Copy) are up to date.</li><li>Impart trainings and development for new joiners, Technical Trainees etc.</li><li>Coordinate with Manufacturing Engineer for new product development and process improvement.</li><li>Assessing resource requirements and opportunity for Automation and Process Productivity improvement</li><li>Review of deployment</li><li>Review ISO documents and update, Engage in ISO audits.</li><li>Visit vendors for Assembly tooling assessment (Capability, Know How &amp; Capacity)</li><li>Monitoring of AM and PM and Effectiveness&nbsp;</li><li>Able to run the machine and instruct and train technicians to run the machine</li><li>CCD and PLC and Electrical Knowledge Preferably</li></ul> Requirements: <ul><li>Bachelor in Mechanical Engineering major or Electrical Engineering</li><li>10+ years’ experience and practitioner in the automation assembly and Tooling Design &amp; Development</li><li>CAD Knowledge Must, preferably Pro E / Creo &amp; Auto-cad, Solidworks, HMI (Human Machine interface).</li><li>DFM analysis, New automation or manual assembly / Tooling RFQ.</li><li>Assembly line Tooling &amp; Tool Debugging Knowledge.&nbsp;</li><li>Computer Knowledge, MS Office etc, SAP knowledge added advantage</li><li>Integrity; Accountability; Communication; Outgoing&nbsp;</li><li>Ergonomic and lean manufacturing practitioner</li><li>Advance digital acumen, MES (Manufacturing Execution System) and traceability.</li></ul>

Responsibilities: <ul><li>Own and lead the process engineering function for cleanroom assembly, end-of-line test and pre-packing, ensuring safe, compliant and capable processes that meet cost, quality, safety and delivery targets.</li><li>Define department objectives, KPI dashboard and governance (e.g., NPI definition and handover lead times, first pass yields, failure rates, quality qppm) and drive execution through standard routines and reviews.</li><li>Lead, coach and develop a team of process engineers / technicians; set clear expectations, provide performance feedback, support competency development and ensure effective succession and talent retention.</li><li>Plan and manage resources (headcount, skills, priorities) to support daily manufacturing needs, escalations, and strategic projects; balance workload across product series and value streams.</li><li>Own process engineering deliverables for NPI or transfer projects: feasibility, process concept, capacity planning, industrialization roadmap, and readiness reviews to ensure on-time SOP.</li><li>Lead cross-functional collaboration with Product Design, Quality, Production, Maintenance, Supply Chain and global counterparts to deliver robust processes supported by Design for Manufacturing / Assembly / Test (DFM / DFA / DFT) improvements.</li><li>Own the strategy and budget for process equipment, tools, fixtures, testers and workstations; approve specifications, manage procurement, acceptance, validation and release to production.</li><li>Drive continuous improvement programs (CIP / Darwin) to improve throughput, cycle time, productivity and cost; support CIP events and ensure sustained gains through standardization.</li><li>Ensure effective utilization of PFMEA and other quality tools to manage and mitigate quality risks during process development, acceptance and production release.</li><li>Develop engineering procedures to govern end-to-end process engineering activities across process design, definition, industrialization, handover, sustainment and continuous improvements.&nbsp;</li><li>Ensure upkeep of process work instructions in D365 via Process Control System as per global standards, including revisioning control based on valid change management procedures.</li><li>Ensure robust management of engineering changes (ECR), process changes and deviations, including impact assessment, validation and controlled implementation.</li><li>Own 8D problem-solving governance for process-related issues, ensure timely root-cause containment / corrective and preventive actions, lessons learned, and clear communication to stakeholders.</li><li>Drive safety, ergonomics and regulatory / ISO compliance for process engineering scope; ensure safe equipment and process design through risk assessments.</li><li>Drive the sustainable deployment of state-of-the-art engineering solutions on the assembly shop floor to enhance quality control through robust error-proofing (poka‑yoke) mechanisms and digitalizations.</li><li>Act as the site focal point to align with global and process engineering counterparts on technology roadmaps, best practices and standardization.</li><li>Manage departmental reporting, change control and communication: provide clear status updates, risks and mitigation plans to operations and leadership.</li><li>Support ad hoc tasks as assigned by superior.</li></ul> Requirements: <ul><li>8–12+ years’ experience in manufacturing/precision mechanical assembly (high-mix preferred), with demonstrated ownership of end-to-end process engineering (process development/industrialization, cleaning / helium leak testing, and controlled-environment or cleanroom assembly where applicable).</li><li>Bachelor’s/Master’s degree in Mechanical, Manufacturing, Industrial Engineering or equivalent; formal training in Lean/Six Sigma and structured problem solving will be added advantage.</li><li>Proven people leadership experience (hiring, coaching, performance management) with the ability to lead technical teams and influence cross-functional stakeholders to deliver manufacturing results.</li><li>Strong written and spoken English communication skills, including the ability to produce clear technical documentation, present KPI performance, and communicate risks / mitigation to leadership.</li><li>Strong understanding of mechanical / pneumatic / electromechanical systems, process equipment and tooling, with experience defining specifications, commissioning, qualification / validation and release to production.</li><li>Demonstrated ownership and governance mindset - sets clear standards, drives disciplined execution, and maintains strong internal / external customer focus.</li><li>Strong prioritization, planning and project management skills to manage multiple workstreams (daily support, escalations, NPI, CIP) under tight timelines and resource constraints.</li><li>Strong technical acumen in quality planning processes especially in definition of process controls based on PFMEA.</li><li>Data-driven operational leadership: builds KPI dashboards, drives root-cause problem solving (8D / A3), and delivers sustained improvements in yield, throughput / cycle time and qppm.</li><li>Strong stakeholder management and change leadership - able to drive alignment across Production, Quality, Maintenance, Supply Chain and global counterparts; comfortable leading reviews and escalations.</li></ul>

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>

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94 capacity test runs Jobs found

Scientist I, Quality Control LTS

Principal/Staff, Firmware and Product Test (SSD)

Process Technician

Mechanical Engineer

Manager, UAT Analyst - Retail Operational Readiness Centre

Procurement Specialist

Supply Planning & Order Management Sr Specialist

Manufacturing Engineer

Process Engineering Manager

Site Quality Leader

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94 capacity test runs Jobs found

Scientist I, Quality Control LTS

Principal/Staff, Firmware and Product Test (SSD)

Process Technician

Mechanical Engineer

Manager, UAT Analyst - Retail Operational Readiness Centre

Procurement Specialist

Supply Planning & Order Management Sr Specialist

Manufacturing Engineer

Process Engineering Manager

Site Quality Leader

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