Quality Manager (Albright Location)

Sterling Manufacturing is a world-class plastics manufacturing solutions provider. Sterling is a dynamic and rapidly growing company and an industry leader in precision injection molding, tool design, rapid prototyping and value-added services. Primary markets include medical, consumer products, defense and aviation. Sterling operates a state-of-the art facility including brand new Engel equipment and a beautiful 5,000 square foot ISO Class 8 cleanroom. 

Open position is at our Albright Silicone facility in Leominster, MA

  • Overall responsibility for the continued development and maintenance of our ISO 13485:2016 QMS system
  • Candidate will have responsibility to manage QC technicians on all shifts.
  • Will manage all aspects of validations from a Quality standpoint, including protocol creation, product specification review, data collection, data entry, statistical analysis, report generation, gage R&R activities, IQ/OQ/PQ as appropriate, etc.
  • Will interact with process engineering and customers on a regular basis.
  • Must ensure documentation compliance with process engineering.
  • Will evaluate and analyze FAI data, SPC data, Cpk data, generate reports, prepare and present evaluations to management team as appropriate.
  • Must support the realization of new products through design, validation, qualification and production.
  • Will determine production measurement techniques, equipment, and personnel requirements. Must train personnel as necessary.
  • Will aid in the ongoing implementation of Lean Manufacturing processes and continuous improvement techniques.
  • Will be a direct report to the Sterling Manufacturing Quality Manager

Desired Skills and Experience

  • Must have experience working in a Certified Clean Room (Class 8), with various medical devices and products.
  • Experience and understanding of ISO 13485
  • Certified Internal Auditor a plus
  • Must have experience with metrology equipment, and CMM experience is a plus.
  • Strong product dimensional analysis skills, including application of GD&T, MiniTab, and MS Office.
  • Must be a self-motivated team player with the ability to lead the quality team by example. Must be hands-on and maintain a visible presence on the manufacturing floor.
  • Must have at least 5 Years of medical device manufacturing and plastics experience, within an ISO environment.
  • Candidate should be energetic and willing to attack new and unique challenges.

This is a salaried position with an excellent benefits package including 401(k), Medical, Dental, Vision, and the opportunity to join our dynamic growing company.

Must be fully vaccinated for COVID-19 to be eligible for employment at all Sterling Manufacturing Company locations.

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