Quality Systems Post Market Staff Lead

BD

San Diego, CA, USA
Annual range: $155,900.00 - $257,300.00 usd; base ...
Fully remote
7 years medical device qa experience
5 years iso 14971 risk management
Fda regulatory response drafting
This role ensures robust governance of post-market quality processes including CAPA management and field action decisions

Job Summary

  • This role ensures robust governance of post-market quality processes including CAPA management and field action decisions.
  • The position requires evaluating quality signals to determine escalation and aligning investigations with regulatory requirements.
  • BD offers a culture that values learning, growth, and the opportunity to make transformative solutions in healthcare.

Matching Summary

This role ensures robust governance of post-market quality processes including CAPA management and field action decisions.

Salary

Annual range: $155,900.00 - $257,300.00 USD; Base salary based on experience and location; Competitive benefits package offered

Skills & Requirements

Must-have

  • 7 years medical device QA experience
  • 5 years ISO 14971 risk management
  • FDA regulatory response drafting
  • CAPA investigation and verification
  • Health Hazard Evaluation facilitation

Nice-to-have

  • Cross-functional leadership capabilities
  • Data analytics for KPI monitoring
  • Continuous improvement mindset
  • Strong problem-solving skills

Key Requirements

  • Bachelor's degree in Engineering or Life Sciences
  • Minimum 7 years progressive QA experience
  • Minimum 5 years hands-on risk management expertise
  • Direct FDA communication experience required

Work Rights

Not specified

Tailored Resume

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