The role requires leading the development and implementation of Quality and Regulatory requirements while ensuring adherence to FDA regulations and company policies
Job Summary
The role requires leading the development and implementation of Quality and Regulatory requirements while ensuring adherence to FDA regulations and company policies.
Candidates must utilize Lean Leadership and Six Sigma methodologies to drive continuous improvement, reduce waste, and solve complex manufacturing issues.
The position offers a comprehensive benefits package including immediate eligibility for medical, dental, vision, disability, life insurance, and a 401(k) plan with matching contributions.
Matching Summary
The role requires leading the development and implementation of Quality and Regulatory requirements while ensuring adherence to FDA regulations and company policies.
Salary
Base: $130,350-$173,800; Bonus/Equity: Cash-based incentive program included; 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
Nice-to-have
Six Sigma Black Belt certification
Lean manufacturing techniques
Strong leadership and mentoring skills
DMAIC problem solving approaches
Key Requirements
Minimum 10 years of 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