Staff Quality Engineer (post Market)

Bdjobs

San Diego, CA, USA
Base: $124,700.00 - $205,800.00 usd annual; bonus/...
5 years quality experience in medical device industry
5 years post-market quality and complaint trending
Advanced knowledge of iso 14971 and iso 13485 standards
The Senior Quality Engineer will ensure timely completion of design control deliverables and execute post-market activities for medical products

Job Summary

  • The Senior Quality Engineer will ensure timely completion of design control deliverables and execute post-market activities for medical products.
  • Candidates must oversee risk management using ISO14971 standards to define critical quality attributes and present risk/benefit justifications to leadership.
  • BD offers a comprehensive Total Rewards program and a culture that supports face-to-face collaboration and professional growth.

Matching Summary

The Senior Quality Engineer will ensure timely completion of design control deliverables and execute post-market activities for medical products.

Salary

Base: $124,700.00 - $205,800.00 USD Annual; Bonus/Equity: Not specified; Benefits: Comprehensive Total Rewards program including compensation and benefits packages

Skills & Requirements

Must-have

  • 5 years Quality experience in medical device industry
  • 5 years Post-Market Quality and complaint trending
  • Advanced knowledge of ISO 14971 and ISO 13485 standards
  • Expertise in FDA regulations and design controls
  • Bachelor's degree in engineering field

Nice-to-have

  • Experience with Hazard Analysis or FMEA
  • ASQ Certified Quality Engineering credential
  • Six Sigma credentials preferred
  • Strong oral and written communication skills
  • Ability to work in rapidly changing environments

Key Requirements

  • Bachelor's degree in engineering
  • Minimum 5 years medical device quality experience
  • Minimum 5 years post-market quality experience
  • Knowledge of FDA/ISO regulations
  • Engineering qualification required

Work Rights

Not specified

Tailored Resume

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