QS Associate Engineer

Compounding Solutions is a leading manufacturer of custom thermoplastic materials, primarily supporting the medical device industry. Our manufacturing site in Lewiston, Maine supplies the largest medical companies located here in the US and in 39 countries worldwide. The materials we produce save and improve the quality of people’s lives. For over 20 years, Compounding Solutions has sustained consistent growth by focusing on continuous improvement, investing in R&D and innovative technologies, maintaining a robust quality system, and offering outstanding customer service. We seek a motivated and detail oriented individual to join our Quality Systems group. This individual will become an integral part of the team to maintain our compliance to ISO 13485:2016 and to seek opportunities for improvement. This employee will consistently monitor and measure activities within the organization to ensure processes are functioning as expected and regulatory obligations are being met. This individual will periodically interact with and report to top management as needed for specific tasks or to provide an overall summary of the ongoing performance of the quality system. Responsibilities Maintaining quality system compliance to ISO 13485:2016 Creating, implementing, or updating procedures or documents as needed. Managing the structure and execution of internal audits Participating in audits conducted by our customers or certification bodies. Managing and reporting on customer complaints Managing and reporting on Corrective Action Requests (CARs), Supplier Corrective Action Requests (SCARs), and Preventative Action Requests (PARs) Customer surveys related to quality systems Scheduling and facilitating QMS reviews by management Tracking quality objectives Ensuring document control Tracking and controlling non-conforming product Job Requirements BS in Engineering or Science Understanding of scientific method, the importance of proper documentation Willingness to learn Understanding of basic math fundamentals General computer knowledge Self-motivated Experience in working with a Quality System, preferably ISO 13485 or secondly ISO 9001 is a plus, but not a requirement Effectively communicate verbally and in writing Job Type: Full-time Pay: $60,000.00 - $90,000.00 per year Benefits: 401(k) 401(k) matching Dental insurance Disability insurance Health insurance Health savings account Life insurance Paid time off Parental leave Professional development assistance Referral program Tuition reimbursement Vision insurance Schedule: Day shift Monday to Friday Experience: Quality: 3 years (Preferred) Shift availability: Day Shift (Preferred) Work Location: In person