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 applies and interprets relevant medical device standards and regulations as they related to design and development activities to advise design teams on quality and compliance impacts of design decisions, ensures robust design controls, and maintains Design History Files (DHFs).
Johnson & Johnson is hiring for a Sr. Quality Engineer, Design Assurance – Shockwave (Reducer) to join our team located in New Brighton, MN.
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: Vacation –120 hours per calendar year, Sick time - 40 hours per calendar year, Holiday pay –13 days per calendar year, Work, Personal and Family Time - up to 40 hours per calendar year, Parental Leave – 480 hours, Bereavement Leave – 240 hours, Caregiver Leave – 80 hours, Volunteer Leave – 32 hours, Military Spouse Time-Off – 80 hours
Skills & Requirements
Must-have
Design Verification and Validation
Risk Management ISO 14971
FMEA development and management
ISO 13485 and FDA GMP
Statistical software proficiency
Cross-functional collaboration skills
Nice-to-have
Human factors and usability engineering
Lean Six Sigma certification
PLM and MES systems experience
Cardiovascular product development
Key Requirements
Bachelor's degree with 5+ years or Master's degree with 3+ years medical device experience
Experience with Test Method Validation
Experience with ISO 14971
Experience with 21 CFR Part 820 / FDA QMSR
Experience with EU MDR (2017/745)
Strong statistical and analytical skills
Experience supporting regulatory inspections and audits