Quality Engineer

5 days ago

San Diego, CA, United States BioTalent Full time

We're seeking a hands-on and detail-oriented Quality Engineer to join our growing Quality Assurance and Regulatory Affairs team. The ideal candidate will have a strong engineering background with experience across the product lifecycle-from design to manufacturing-within the medical device industry. The title of Senior Quality Engineer is available for candidates with deeper experience and demonstrated leadership.

Role/Responsibilities

  • Partner with R&D to define product requirements and release criteria; support design reviews and technical documentation
  • Lead risk management activities (FMEA/DFMEA/PFMEA) and maintain traceability throughout the design process
  • Author, maintain, and execute design verification and validation (V&V) protocols and reports; lead formal V&V testing
  • Execute and document intended-use validations and computer system validations
  • Draft, revise, and maintain SOPs aligned with FDA QMSR and ISO 13485; support internal audits and monitor quality metrics
  • Contribute to regulatory submissions (e.g., 510(k)); prepare Letters to File, labeling, and supporting documentation; ensure alignment with applicable regulations and standards
  • Oversee supplier qualification; conduct supplier audits; drive SCARs and supplier improvement actions; communicate quality issues with suppliers
  • Develop inspection plans; support inventory control, equipment/tool maintenance/calibration, and process validations (IQ/OQ/PQ)
  • Collaborate across Operations, Manufacturing, and Supply Chain to communicate risks, mitigations, and timelines
Requirements
  • Bachelor's degree in Engineering or a related technical field
  • 2-4 years of quality engineering experience in the medical device industry (additional experience considered for Senior title)
  • Working knowledge of FDA QMSR, ISO 13485, and ISO 14971; experience with lifecycle documentation and QMS development in regulated environments
  • Preferred familiarity with 510(k) submissions and/or EU MDR technical documentation
  • Preferred familiarity with early-stage/startup environments
  • Strong technical writing, attention to detail, data-driven problem solving, and excellent communication/stakeholder management
  • Strategic and hands-on, collaborative, adaptable, and mission-driven

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