Find & Apply For Quality Control Systems Manager Jobs in Colebrook, New Hampshire

Prepco Medical Job Description — Quality Assurance Manager Revised September 2026 Position Summary The Quality Assurance Manager develops, implements, and oversees the Quality Management System (QMS) and quality control functions for Prepco Medical, a medical device contract manufacturer operating under

ISO 13485

2016. The position is responsible for ensuring that products and processes meet established quality standards, customer specifications, and applicable regulatory requirements. This position reports directly to the President/Owner. This is currently an individual-contributor role with no direct reports. It carries primary responsibility for the design, documentation, and ongoing operation of the quality system, and requires the regular exercise of discretion and independent judgment on matters of significance to the business — including the disposition of nonconforming material, the closure of corrective actions, and sign-off on quality records. Supervisory responsibility may be added to this role in the future as the department grows. Essential Duties and Responsibilities Maintain and continuously improve Quality Management System (QMS) documentation in accordance with

ISO 13485

2016. Formulate, document, and maintain quality control standards, work instructions, and ongoing quality objectives.

Own the internal audit program:

schedule, conduct or coordinate internal audits, and track findings to closure. Manage the Corrective and Preventive Action (CAPA) system, including root cause investigation, effectiveness verification, and closure. Investigate, document, and resolve customer quality complaints; evaluate complaints for reportability under applicable medical device reporting requirements (e.g., 21 CFR 820.198 / 803) and escalate as needed. Oversee disposition of nonconforming material, including Material Review Board (MRB)-type decisions on use-as-is, rework, repair, or scrap. Manage supplier quality activities, including incoming inspection oversight and supplier corrective action requests. Own the calibration program for measurement and test equipment, ensuring equipment is calibrated, tracked, and controlled per QMS requirements. Monitor and direct environmental and process test functions relevant to product and packaging validation. Support risk management activities (e.g., ISO 14971) where the QMS touches design or process risk files. Administer quality training programs, including developing training content, maintaining training records, and verifying employee qualification — this duty involves program administration rather than supervision of other trainers. Create work orders and perform in-process and incoming inspections as needed. Compile and present quality data and metrics in support of periodic management review. Serve as the primary point of contact for

ISO 13485 QMS

management and external audits (e.g., notified body, customer audits). Core Competencies Technical Capacity Organizational Skills Problem Solving / Analytical Thinking Customer Focus Time Management Cross-Functional Influence — ability to drive compliance and quality outcomes across production and engineering without direct supervisory authority Measurement Equipment Proficiency (calipers, verniers, optical comparator) Qualifications Associate's degree in Mechanical Engineering, a related technical field, or an equivalent combination of education and experience (minimum requirement). Bachelor's degree in Mechanical Engineering or a related technical field preferred. Minimum 5 years of quality management experience within an ISO 13485-compliant environment; equivalent

ISO 9001

experience considered as supplementary qualifying experience. ASQ certification (e.g., CQE, CQA, or CMQ/OE) preferred. Working Conditions Manufacturing operations are performed in environmentally controlled clean rooms. This requires the employee to wear a smock, head net, and beard cover (if applicable), and to adhere to Good Manufacturing Practices at all times while on the production floor. Administrative and documentation work is performed in a typical office environment. Physical Requirements The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job, with or without reasonable accommodation. Frequent walking throughout the facility during in-process and incoming inspections. Occasional bending, reaching, and lifting associated with incoming inspection and stocking of product; this includes the ability to lift and carry packages up to 50 pounds. Prolonged periods of sitting or standing while performing documentation and computer-based QMS work. Other Duties This job description is not designed to cover or contain a comprehensive listing of all activities, duties, or responsibilities required of the employee. Duties, responsibilities, and activities may change at any time, with or without notice, at the discretion of the Company.

Job Type:

Full-time Pay:

Up to $50.00 per hour

Benefits:

401(k) 401(k) matching Health insurance Paid time off Professional development assistance Tuition reimbursement

Work Location:

In person