Sr. Quality Engineer (post Market)

BDX

San Diego, CA, USA
Base: $102,000.00 - $168,200.00 usd annual; bonus/...
Fully remote
Design control and risk management
Post-market quality complaint trending
Quality management systems compliance
The Senior Quality Engineer will ensure the timely completion of design control deliverables and execute post-market activities to support product safety and quality

Job Summary

  • The Senior Quality Engineer will ensure the timely completion of design control deliverables and execute post-market activities to support product safety and quality.
  • BD is a global medical technology company that fosters a culture of learning, growth, and innovation to advance the world of health.
  • BD prioritizes on-site collaboration with a minimum of 4 days in-office per week to maintain creativity, innovation, and effective problem-solving.

Matching Summary

The Senior Quality Engineer will ensure the timely completion of design control deliverables and execute post-market activities to support product safety and quality.

Salary

Base: $102,000.00 - $168,200.00 USD Annual; Bonus/Equity: Not specified; Benefits: Competitive compensation and benefits programs

Skills & Requirements

Must-have

  • Design control and risk management
  • Post-market quality complaint trending
  • Quality Management Systems compliance
  • ISO 14971 risk management
  • FDA/ISO regulatory knowledge
  • Data analytics for complaints

Nice-to-have

  • Hazard Analysis or FMEA experience
  • Verification and validation knowledge
  • Strong oral and written communication
  • Adaptability to changing environment
  • Team collaboration skills
  • Critical thinking and problem solving

Key Requirements

  • Bachelor’s degree in engineering
  • 4 years Quality, Design Controls, Risk Management experience
  • 3 years Post-Market Quality experience
  • Advanced knowledge of FDA/ISO regulations
  • Experience with ISO 14971 and ISO 13485

Work Rights

Must be fully vaccinated against COVID-19

Tailored Resume

Cover Letter