*Assist with continued development and maintenance of ISO 9001-2008 QMS system. Familiarity with ISO 13485:2016 is an advantage.
*Work with QC technicians on all shifts and Quality Manager.
*Lead new program validations, usually IQ/OQ/PQ or equivalent, including protocol creation, product specification review, metrology, data collection, data entry, statistical analysis, report generation, gage R&R activities, etc.
*Must have experience with metrology equipment including CMM.
*Regularly interface with customers.
*Ensure documentation compliance with process engineering.
*Evaluate and analyze FAI data, SPC data, Cpk data, generate reports, prepare and present evaluations to management team as appropriate.
*Support customer requirements through development, validation and ongoing production.
*Determine production measurement techniques, equipment, and personnel requirements. May assist with training of Technicians.
*Strong dimensional analysis skills, including application of GD&T, MiniTab, and MS Office.
*Aid in the ongoing implementation of Lean Manufacturing processes and continuous improvement techniques.
*Must have at least 5 years of medical device manufacturing and plastics experience, within an ISO environment.
*Must be a self-motivated team player with the ability to lead by example. Must be hands-on and maintain a visible presence on the manufacturing floor.
Candidate should be energetic and willing to attack new and unique challenges. Sterling offers an excellent benefits package including 401K, medical, dental and the opportunity to join our dynamic, growing company.
We are an Equal Opportunity Employer.