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Senior Quality Engineer

Element Science· Quality
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Redwood City, CA$104k - $132kfull-timePosted 3w ago

About the role

Senior Quality Engineer to support quality, reliability, and continuous improvement of medical device technology, with leadership of supplier quality and collaboration across Engineering, Manufacturing, Supplier Quality, Operations, and Supply Chain throughout the commercial product lifecycle.

Responsibilities

  • Sustaining Quality: serve as the Quality Engineering partner for sustaining engineering and post-market activities; provide Quality oversight for product, component, manufacturing, supplier, and design changes including verification and validation requirements; support nonconformance, complaint investigations, and CAPA activities with root cause analysis and effectiveness verification; partner with Engineering and Operations to address product and manufacturing issues with sustainable corrective and preventive actions; maintain and update Risk Management Files per ISO 14971 incorporating post-market information, changes, complaints, and identified risks; analyze quality and product performance metrics to identify trends and drive improvements; provide technical Quality expertise for electrical and electromechanical product issues and changes.
  • Supplier Quality: manage supplier evaluation, selection, qualification, re-qualification and ASL maintenance; plan and perform onsite and remote supplier audits for ISO 13485 and regulatory compliance; establish supplier quality agreements; monitor supplier quality performance via scorecards and reviews, drive SCARs to closure; define incoming inspection requirements, sampling, and first article inspection; lead MRB disposition of supplier-related nonconformances; review supplier process capability and validation evidence; lead supplier quality improvement initiatives.
  • Manufacturing & Process Quality Oversight: partner with Manufacturing Engineering on process characterization, capability (Cpk/Ppk), SPC, pFMEA, and IQ/OQ/PQ validation; review and approve protocols and reports with risk-based, statistically justified acceptance criteria; develop and execute verification and validation plans for sustaining activities including test method validation.
  • Quality System & Leadership: support continuous improvement of Quality System procedures, SOPs, and Work Instructions; mentor junior engineers and promote strong Quality Engineering practices across cross-functional teams; perform other responsibilities as assigned.

Qualifications

  • 5+ years of Quality Engineering or Sustaining Engineering experience within the medical device industry, preferably supporting commercial electromechanical products
  • Demonstrated experience with post-market and sustaining quality activities (nonconformances, CAPAs, change control, root cause investigations, verification and validation)
  • Working knowledge of ISO 13485, FDA Quality System requirements, ISO 14971, and IEC 60601-1
  • Experience applying risk management principles throughout the commercial product lifecycle
  • Strong technical problem-solving and root cause analysis skills
  • Bachelor’s degree in Engineering, Science, or related technical discipline; Master’s degree a plus
  • Ability to work effectively across Engineering, Manufacturing, Operations, Supplier Quality, and cross-functional teams
  • Strong organizational skills and ability to manage multiple priorities and meet deadlines
  • Excellent written and verbal communication skills

Skills

Required:Quality engineeringCAPA and nonconformance handlingRisk management (ISO 14971)Regulatory standards (ISO 13485, FDA QSR, IEC 60601-1)Process capability and statistical methodsSupplier quality managementChange controlCross-functional collaborationCommunication & mentoring

Benefits

  • Stock Options
  • 90% employer-paid medical, dental, and vision insurance
  • Company-paid Basic Life Insurance
  • 401(k) retirement plan (Traditional and Roth)
  • Competitive Paid Time Off
  • Paid Holidays
  • FSA (Flexible Spending Accounts)
  • HSA (Health Savings Account)
  • Employee Assistance Program through PEO
Last updated Oct 9, 2026. Interested? Apply on the company site.

About Element Science

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