Quality Assurance Specialist
3 weeks ago
The Quality Assurance Specialist will be responsible for assisting in the development, implementation, and oversight of the quality system of restor3d while providing support to operations/manufacturing, manufacturing engineering, and product development. This role will have a direct impact on the long-term future of our company.
This position is an on-site position at our Wilmington, MA location. The estimated salary for this role is $80,000 - $110,000 per year, based on industry standards and location.
Duties and Responsibilities:
- Implement quality system processes to support production of safe and effective implantable medical devices.
- Identify and implement solutions for continuous improvements for the quality system, Quality Control inspection lab, manufacturing processes, and product designs.
- Develop and maintain strong internal working relationships across the company.
- Understand the objectives, responsibilities, and mission of the Quality department and work towards those goals.
Qualifications and Experience:
- Bachelor of Science in Engineering, Mechanical Engineering, Science, Biomedical, or Materials Science.
- 0 – 5 years of experience with a comprehensive knowledge of Medical Device regulations including FDA 21 CFR 820 and other applicable international standards with hands-on experience in working within a quality system under regulatory requirements.
- Proficiency with Microsoft Office (Word, Excel, PowerPoint).
- Ability to travel as needed (≤ 10% of the time).
Physical Requirements:
- Position may involve the use of basic hand tools and inspection and cleaning equipment.
- Position may involve handling of or exposure to metallic powders, mill coolant, tapping fluid, and polymeric resins.
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