BD is seeking a Distinguished Quality Engineer in Irvine, CA, who will lead advancements in quality engineering methodologies and ensure compliance in medical technology products. The ideal candidate will have extensive experience in quality systems, regulatory standards, and risk management
Job Summary
This role serves as a recognized technical leader driving significant advancements in quality engineering methodologies across the organization.
The successful candidate will lead regulatory audits for FDA, ISO, and MDR while ensuring the highest standards of product safety and efficacy.
BD offers a comprehensive Total Rewards program designed to attract high-quality talent through competitive compensation and performance-based culture.
Matching Summary
Match Score: 85
BD is seeking a Distinguished Quality Engineer in Irvine, CA, who will lead advancements in quality engineering methodologies and ensure compliance in medical technology products. The ideal candidate will have extensive experience in quality systems, regulatory standards, and risk management.
Salary
Base: $155,900.00 - $257,300.00 USD Annual; Bonus/Equity: Not specified; Benefits: Comprehensive Total Rewards program including reward and recognition opportunities
Skills & Requirements
Must-have
12 years engineering experience
FDA 21 CFR Part 820 compliance
ISO 13485 global standards expertise
Six Sigma Black Belt methodology
Electro-mechanical system design knowledge
Risk management tools FMEA PHA FTA
Nice-to-have
Advanced statistical software proficiency
Strong leadership and coaching skills
Ability to influence organizational change
Experience with hemodynamic monitoring systems
Excellent presentation and negotiation skills
Key Requirements
Bachelor's degree plus 12 years experience OR Master's plus 11 years OR PhD plus 8 years
End-to-end product lifecycle experience from development to post-market
Deep understanding of global medical device regulations