The role requires leading the development and implementation of Quality and Regulatory requirements including FDA regulations and company policies
Job Summary
The role requires leading the development and implementation of Quality and Regulatory requirements including FDA regulations and company policies.
Candidates must apply Lean manufacturing techniques and Six Sigma approaches to continuously improve cycle times and reduce waste.
The position offers a comprehensive benefits package including immediate eligibility for medical, dental, vision, disability, life insurance, and a 401(k) plan with matching.
Matching Summary
The role requires leading the development and implementation of Quality and Regulatory requirements including FDA regulations and company policies.
Salary
Base: $130,350-$173,800; Bonus/Equity: Cash-based incentive program; Benefits: Medical, dental, vision, disability, life insurance, adoption benefits, parental leave, 401(k) match
Skills & Requirements
Must-have
Bachelor of Science in Engineering
10+ years engineering experience
5+ years medical device industry
ISO and regulatory standards knowledge
Process and Test Method Validation IQ OQ PQ PPQ
Nice-to-have
Six Sigma Black Belt certification
Lean Leadership experience
DMAIC problem solving techniques
Mentoring junior staff capabilities
Cross-functional team collaboration
Key Requirements
Minimum 10 years total experience
Minimum 5 years in medical device industry
Bachelor of Science in Engineering required
Master or PhD degree preferred
Knowledge of ISO and regulatory standards mandatory