Senior Quality Engineer

Avive Solutions-posted 3 months ago
$140,000 - $160,000/Yr
Mid Level
Brisbane, CA
101-250 employees
Computer and Electronic Product Manufacturing
Resume
Match Score
Upload and Match ResumeTrack Jobs with Teal

The Senior Quality Engineer will support the development and manufacturing of Avive's electromechanical medical devices. This role will play a critical role in ensuring product quality and regulatory compliance across the product lifecycle, with responsibilities spanning manufacturing support, supplier quality management, and design control.

  • Provide quality engineering support for manufacturing operations (in-house and contract manufacturing).
  • Partner with Manufacturing to establish and maintain robust in-process and final inspection criteria.
  • Support process validation activities (IQ/OQ/PQ) and ensure compliance with ISO 13485 and FDA 21 CFR Part 820 requirements.
  • Aid in production ramp-up and collaborate cross-functionally to address issues and drive continuous improvement projects.
  • Develop and maintain the supplier quality program, including supplier selection, audits, and ongoing performance monitoring.
  • Collaborate with Product Development and Manufacturing functions to qualify new suppliers and components.
  • Manage supplier non-conformances and corrective actions to ensure timely and effective resolution.
  • Ensure compliance with design control requirements (21 CFR 820.30, ISO 13485, ISO14971).
  • Author, review, and approve design control documentation (Design History File, risk management files, verification/validation protocols and reports).
  • Support design transfer activities to manufacturing.
  • Collaborate with cross functional teams to ensure design and manufacturing changes are assessed and implemented according to applicable regulations.
  • Champion for quality initiatives and improvements.
  • Perform gap assessment of external standards.
  • Lead root cause investigations and implement effective corrective and preventive actions (CAPAs).
  • Support internal and external audits.
  • Support regulatory submissions as needed.
  • 5+ years of quality or manufacturing engineering experience in medical devices
  • BS in Engineering (preferably Electrical, Mechanical or Biomedical)
  • Strong knowledge of FDA QSR, ISO 13485, ISO 14971, and applicable IEC/ISO standards (e.g., IEC 60601)
  • Strong interpersonal and communication skills
  • Technical knowledge of electromechanical systems and software medical devices
  • ASQ CQE, or related certification a plus.
  • Equal Employment Opportunity
  • Reasonable accommodations for qualified individuals with disabilities
Track Jobs with Teal

Job Search Resources

•
AI Resume Builder
•
Senior QA Engineer Resume Examples
•
Cover Letter Examples

Tools

Career Hubs

Guides

Company

© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service