Base: $94,000 to $168,000 depending on location; b...
Fully remote
7+ years quality engineering experience
External supplier audit experience in medical devices
Iso 13485 and iso 9001 formal training
This role is critical in ensuring that the supply base maintains robust, compliant, and effective Quality Management Systems aligned with regulatory requirements
Job Summary
This role is critical in ensuring that the supply base maintains robust, compliant, and effective Quality Management Systems aligned with regulatory requirements.
The company offers a comprehensive benefits program including generous PTO, a 401k match up to 7%, and stock purchase plans.
Candidates must be willing and able to travel up to 50% domestically and internationally to supplier sites.
Matching Summary
This role is critical in ensuring that the supply base maintains robust, compliant, and effective Quality Management Systems aligned with regulatory requirements.
Salary
Base: $94,000 to $168,000 depending on location; Bonus/Equity: Annual incentive bonus and long-term incentives may be offered; Benefits: Generous PTO, 401k match, HSA contribution, stock purchase plan, education reimbursement
Skills & Requirements
Must-have
7+ years quality engineering experience
External supplier audit experience in medical devices
ISO 13485 and ISO 9001 formal training
Certified Lead Auditor credential required
Proficiency with audit management systems
Nice-to-have
Strong communication and negotiation skills
Understanding of complex manufacturing processes
Ability to assess risk-based improvement opportunities
Experience with ISO 17025 standards
Key Requirements
Bachelor's degree in Engineering or equivalent
Master's degree preferred
US work authorization required without sponsorship