Design Quality Engineer
Danvers, MA
Apply now: Design Quality Engineer, Remote (Ideally Local). The start date is end of February for this 4-month contract position.
Job Title: Design Quality Engineer
Location-Type: Remote
Start Date Is: End of February
Duration: 4 months (Contract, until end of June)
Compensation Range: $55-$63/hour W2
Job Description:
Support design quality initiatives for medical device development, ensuring compliance, risk management, and documentation standards are met.
Day-to-Day Responsibilities:
- Prepare and manage submission documentation.
- Oversee risk management processes for pre-commercial medical devices.
- Ensure compliance with DHF (Design History File) requirements.
- Collaborate with engineers, providing constructive feedback and ensuring adherence to quality standards.
- Work on medical devices, focusing on either disposables or capital equipment.
Requirements:
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Must-Haves:
- 4 years of experience in design quality engineering.
- Strong experience with submission documentation and risk management.
- Prior work in medical device quality for disposables or capital equipment.
- DHF experience.
- Ability to effectively push back on engineers while maintaining professional communication.
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Nice-to-Haves:
- Experience with client's product lines or similar high-complexity medical devices.
Soft Skills:
- Strong communication and collaboration skills.
- Ability to challenge engineers in a respectful and productive manner.
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