Base: $79,000.00 - $127,650.00; bonus/equity: not ...
Design verification and validation
Risk management iso 14971
Fmea development and management
The Senior Quality Engineer (Design Assurance) is responsible for ensuring medical devices are designed, developed, and transferred to manufacturing in compliance with applicable quality system and regulatory requirements
Job Summary
The Senior Quality Engineer (Design Assurance) is responsible for ensuring medical devices are designed, developed, and transferred to manufacturing in compliance with applicable quality system and regulatory requirements.
This role partners closely with R&D, Manufacturing, Regulatory Affairs, Clinical Affairs, and Marketing to provide hands-on Design Assurance support throughout new product development.
The anticipated base pay range for this position is : $79,000.00 - $127,650.00.
Matching Summary
The Senior Quality Engineer (Design Assurance) is responsible for ensuring medical devices are designed, developed, and transferred to manufacturing in compliance with applicable quality system and regulatory requirements.
Salary
Base: $79,000.00 - $127,650.00; Bonus/Equity: Not specified; Benefits: Eligible for Company's consolidated retirement plan (pension) and savings plan (401(k)), long-term incentive program, vacation, sick time, holiday pay, Work/Personal/Family Time, Parental Leave, Bereavement Leave, Caregiver Leave, Volunteer Leave, Military Spouse Time-Off
Skills & Requirements
Must-have
Design Verification and Validation
Risk Management ISO 14971
FMEA development and management
ISO 13485 compliance
FDA GMP / QMSR
Nice-to-have
Cross-functional collaboration skills
Self-directed and accountable
Contribute to regulatory submissions
Human factors and usability engineering
Key Requirements
Bachelor's degree with 5+ years or Master's degree with 3+ years of medical device experience
Hands-on experience with Test Method Validation
Experience with statistical software (e.g., Minitab)
Experience supporting regulatory inspections and audits