Quality Assurance Specialist

3 weeks ago


Wilmington, Massachusetts, United States restor3d Full time
Job Summary

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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