Head, Wholesale Operations Readiness Centre, WORC

Sr. Manager, Quality & Reliability Engineering

Scientist I, Quality Control LTS

Staff/Principal Engineer, NAND TD, RDA

Principal/Staff, Firmware and Product Test (SSD)

Electrical Engineer – Industrial Power

Mechanical Engineer

Manager, UAT Analyst - Retail Operational Readiness Centre

Process Engineering Manager

Site Quality Leader

Responsibilities: <ul><li>Lead and manage multiple teams to drive project initiatives and execution</li><li>Oversees WORC operations and handle escalation cases</li><li>Work closely with Center of Excellence and Head office in project planning, resource management</li><li>Gather and understand Business Requirements and Functional Specs/User Story documents</li><li>Ensure the team provides 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>Prepare, review and submit management reports as required by the Bank’s Software Development Framework</li><li>Prepare and submit weekly/biweekly/monthly reports for assurance check</li><li>Foster a continuous improvement and innovative culture to drive efficiency towards excellence</li></ul> Requirements: <ul><li>Bachelor’s degree</li><li>Minimum 10 to 15 years of experience preferably in financial institutions</li><li>Well-versed in operations especially Swift standard in either Cash Management/ Trade Finance/ Loans/ Channels operations</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>Experience in managing multiple teams</li><li>Able to take ownership of issues and take them to closure</li><li>Strong stakeholder management skills across various disciplines and levels</li><li>Mature individual with strong leadership, influencing and problem resolution skills</li><li>Lead human resource planning, development and staff management</li></ul>

Responsibilities: <ul><li>Lead a global team of Advanced Quality Engineers in support of all new product introductions for a Strategic Product Line Portfolio within the Digital Data Networks (DDN) business unit. Lead all AQE activities from project inception to product launch and introduction.</li><li>Participate in the project Kick-off Meetings, support project team development for internal requirements, customer specific requirements, Risk Priority Number (RPN) reductions, analyze SPC data, etc.</li><li>Serve as the liaison between engineering and the plants on new product introductions to ensure robust process capability on all programs.</li><li>Attend project meetings and APQP driven events with the customers and the Project/Program Management Team.</li><li>Document the results for specific program characteristics and ensure the internal and external requirements are met including deviations.</li><li>Accountable for developing and driving on time delivery of Control Plans, Capability Studies, Part drawings, Inspection Instructions, Gage design and R&amp;R, DFMEAs, PFMEAs, AFMEAs for all assigned projects. Ensure the products developed are Designed for Manufacturing &amp; Assembly (DfMA) and are launched capably of meeting internal requirements and customer requirements.</li><li>Understand product requirements and define/approve Design Validation Test (DVT) and quality plans to ensure products meet the product specifications.</li><li>Authorize and approve that all Design Validation Test (DVT) results meet product specifications and customer requirements.</li><li>Actively participate in early product Concept Reviews and Design Review meetings with the Product Development Engineering (PDE) for the assigned product, related tooling and fixturing, and overall quality plans.</li><li>Generate and/or champion 8-Ds for the prototype process including 8-Ds for problem solving, test failures, and prototype failures.</li><li>Complete the Change Control process and identify special characteristics for projects/programs.</li><li>Work in conjunction with the Manufacturing Process Development Engineering (MPDE) teams to ensure the manufacturing process and equipment meets the product’s defined quality level and that the process also meets the capability levels identified for the product and project.</li><li>Assemble and submit PPAP package on time to the customer specific requirement.</li><li>Team with Supplier Quality Engineers to conduct and analyze process capability studies in support of Final Tool Approval (FTAR) for all tools and production lines associated with the project using the Comprehensive Tool Approval Report (CTAR), support completion of Supplier PPAPs.</li><li>Perform Six Sigma Capability Analysis of new equipment/processes to reduce variation.</li><li>Regularly reports to executive management on the overall performance and effectiveness of the Global Supplier Quality Program.</li><li>Drive high performance organization by providing your team routine coaching and feedback, holding your team accountable to meet performance objectives, and providing meaningful development to increase individual/team capability.</li><li>Manage employee well-being by prioritizing work, effectively managing resource loading, and providing flexibility to enable employees to successfully balance their work and personal lives.</li><li>Drive organization effectiveness by structuring your organization in a way that best enables the BU strategy, maximizes resource efficiency and productivity, and provides role clarity and clear lines of accountability.</li><li>Manage the talent in your organization to support the business now and to proactively prepare for the future by identifying organization skillset/role gaps, implementing plans to fill any skillset/role gaps, and assessing current talent fit to ensure the right talent is matched to the right roles to best meet the needs of the business.</li></ul> Requirements: <ul><li>Bachelor/ Master’s degree in technical discipline (Electrical Engineering, Electronics, Mechatronics)</li><li>10+ years of Experience in Quality, Advanced Quality Engineering, and working in global organizations.</li><li>Experience managing engineering teams in cross-functional, multi-site global organizations to drive effectiveness across geographical boundaries and deliver projects with multiple dependencies and constraints.</li><li>Demonstrated ability to forge strong internal working relationships with senior functional counterpart leaders.</li><li>Experience in the use of Lean, Six Sigma, Design for Six Sigma (DFSS), Design for Manufacturability &amp; Assembly (DfMA), Kaizen, 8D and other advanced statistical methods including Design of Experiments (DoE), Statistical Process Control (SPC) and Process Capability (CpK) analysis techniques.</li><li>Comprehensive knowledge and understanding of departmental, company, and corporate procedures and systems, i.e. ISO9000, ISO9001, IATF16949, ISO14001, VDA, PPAP, DFMEAs, PFMEAs, APQP Gate Reviews, GD&amp;T.</li><li>Excellent verbal and written communication skills and the ability to interact professionally with customers, leadership, stakeholders, cross functional teams and subject matter experts.</li><li>Proven track record of being able to work on multiple demanding programs in parallel while maintaining on-time completion of all defined project tasks and deliverables.</li><li>Ability to prioritize responsibilities in a fast-paced dynamic work environment.</li><li>Willingness to travel as required, ~30%</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>

Responsibilities: <ul><li>Own the site-level RDA strategy and annual roadmap aligned to NAND TD technology nodes.</li><li>Lead analysis of experimental and production flows to detect, classify, and trend systematic and random defects.</li><li>Establish, track, and report program health metrics (baseline health, detection rates, false positives, MTTR).</li><li>Direct fast containment for defect excursions: trigger tool quarantines, define hold criteria, and lead 8D corrective actions.</li><li>Architect inspection recipes and sampling strategies; optimize sensitivity, throughput, and cost of ownership.</li><li>Partner with Process Integration, Yield, and Data Science to correlate inspection signals to device performance and yield.</li><li>Influence supplier roadmaps; evaluate, qualify, and release next gen optical/e-beam inspection capabilities.</li><li>Standardize and disseminate Best Known Methods (BKM) across global TD and manufacturing sites.</li><li>Mentor, coach, and upskill engineers; develop succession plans and technical ladders within the RDA domain.</li><li>Champion safety and continuous improvement (CIP); drive kaizen/lean initiatives that improve cycle time and learning velocity.</li></ul> Requirements: <ul><li>Bachelor’s degree with 7+ years relevant semiconductor experience, or Master’s/PhD with 5+ years.</li><li>Minimum 3+ years hands-on RDA experience in semiconductor manufacturing or equipment engineering.</li><li>Demonstrated expertise in defect inspection, process monitoring, and yield learning.</li></ul> Technical Competencies <ul><li>Realtime Defect Analysis (RDA) systems and workflows.</li><li>Optical and e-beam inspection technologies.</li><li>Statistical data analysis, correlation development, and large dataset interpretation.</li><li>Semiconductor process integration and technology development.</li><li>Root cause analysis and systematic problem solving (e.g., 8D, DMAIC).</li><li>Leadership &amp; Behavioral Competencies</li><li>Recognized technical authority with the ability to influence without direct authority.</li><li>Strong mentoring and coaching mindset with proven talent development outcomes.</li><li>Clear, concise communication skills across technical and executive audiences.</li><li>Ownership-driven, execution-focused; comfortable operating in ambiguity.</li><li>Impact &amp; Success Measures</li><li>Reduced defect-related yield loss and faster learning cycles.</li><li>On-time qualification and adoption of next-generation inspection capabilities.</li><li>Uplift in organizational RDA skill depth and succession pipeline.</li><li>Alignment of inspection strategy and capability to future NAND nodes.</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>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>

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>

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>

Skills

Industry

Location

Jobtitle

89 test methods Jobs found

Head, Wholesale Operations Readiness Centre, WORC

Sr. Manager, Quality & Reliability Engineering

Scientist I, Quality Control LTS

Staff/Principal Engineer, NAND TD, RDA

Principal/Staff, Firmware and Product Test (SSD)

Electrical Engineer – Industrial Power

Mechanical Engineer

Manager, UAT Analyst - Retail Operational Readiness Centre

Process Engineering Manager

Site Quality Leader

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

EMPLOYER

TALENT

COMPANY

Contact Us

JOBS BY SKILLS

JOBS BY FUNCTION

JOBS BY INDUSTRY

JOBS BY LOCATIONS

MODEL JOBS

JOBS BY CITY

Skills

Industry

Location

Jobtitle

89 test methods Jobs found

Head, Wholesale Operations Readiness Centre, WORC

Sr. Manager, Quality & Reliability Engineering

Scientist I, Quality Control LTS

Staff/Principal Engineer, NAND TD, RDA

Principal/Staff, Firmware and Product Test (SSD)

Electrical Engineer – Industrial Power

Mechanical Engineer

Manager, UAT Analyst - Retail Operational Readiness Centre

Process Engineering Manager

Site Quality Leader

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

EMPLOYER

TALENT

COMPANY

Contact Us

JOBS BY SKILLS

JOBS BY FUNCTION

JOBS BY INDUSTRY

JOBS BY LOCATIONS

MODEL JOBS

JOBS BY CITY

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