Staff Quality Engineer (post Market)

BD

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 role ensures timely completion of design control deliverables and executes post-market activities for global medical technology products

Job Summary

  • The role ensures timely completion of design control deliverables and executes post-market activities for global medical technology products.
  • Candidates will oversee risk management using ISO 14971 standards to define critical quality attributes and present risk/benefit justifications to executive leadership.
  • BD offers a comprehensive Total Rewards program with competitive compensation ranging from $124,700.00 to $205,800.00 USD annually.

Matching Summary

The role ensures timely completion of design control deliverables and executes post-market activities for global medical technology products.

Salary

Base: $124,700.00 - $205,800.00 USD Annual; Bonus/Equity: Not specified; Benefits: Comprehensive Total Rewards program including performance-based culture

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
  • Bachelor's degree in engineering field required
  • Experience with FDA regulatory guidance and design controls

Nice-to-have

  • ASQ Certified Quality Engineering or Auditor credentials
  • Six Sigma certification preferred
  • Experience with Hazard Analysis or FMEA methodologies
  • Strong oral and written communication skills
  • Ability to adapt to rapidly changing environment

Key Requirements

  • Bachelor's degree in engineering
  • Minimum 5 years medical device quality experience
  • Minimum 5 years post-market quality experience
  • Knowledge of ISO 14971 and ISO 13485
  • FDA/ISO regulatory knowledge

Work Rights

Not specified

Tailored Resume

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