Quality Manager - Medical Manufacturing - Somersworth, NH

The Quality Manager will lead and develop a growing quality team, fostering a culture of accountability while ensuring compliance with ISO 13485 and customer requirements. This role requires a hands-on leader who can drive process improvements, collaborate cross-functionally, and enhance overall product quality in a highly regulated manufacturing environment at our Somersworth, NH facility.

Client Details

My client is a specialized manufacturer of high-performance thermoplastic film components, serving industries that demand precision, reliability, and advanced material expertise. With decades of experience, they have developed proprietary techniques for thermoforming and heat sealing ultra-thin films, enabling the production of complex three-dimensional shapes used in critical applications. Their capabilities extend across various sectors, including medical devices, aerospace, industrial manufacturing, and electronics, where material performance is essential to product functionality.

Founded on a commitment to innovation and problem-solving, my client takes a collaborative approach to engineering solutions, working closely with customers from initial concept through prototyping and full-scale production. Their in-house tooling development and CNC machining capabilities ensure a high degree of customization, while strong relationships with material suppliers allow them to optimize film selection for each application.

Beyond technical expertise, my client fosters a culture centered on balance-ensuring that customers, employees, and partners benefit from every engagement. This philosophy has driven their growth and positioned them as a trusted partner for companies requiring precision-engineered polymer components. Whether supporting next-generation medical technologies or advanced aerospace systems, they remain committed to pushing the boundaries of what is possible with high-performance films.

Description

The Quality Manager, Industrial / Medical Device Manufacturing will:

• Lead and develop the quality team, fostering a culture of accountability and continuous improvement.
• Maintain and enhance the Quality Management System, ensuring compliance with ISO 13485 and customer requirements.
• Monitor and improve key quality metrics, driving company-wide improvements.
• Oversee internal audits and facilitate external audits, ensuring adherence to standards.
• Investigate and resolve customer complaints, implementing corrective actions as needed.
• Serve as the primary quality representative in cross-functional collaboration with manufacturing, engineering, and sales.
• Conduct leadership reviews of the QMS and present findings to management.
• Lead and support training initiatives to enhance quality awareness across teams.
• Drive process improvements using data-driven decision-making and problem-solving methodologies.
• Act as the company's leadership representative for all quality-related matters.
• Ensure timely completion of customer self-surveys and compliance documentation.
• Support new product development and manufacturing changes from a quality perspective.
• Onsite at our Somersworth, NH facility

Profile

• 4 plus years of quality management experience / a quality manager role in an ISO manufacturing environment (medical device, aerospace, or automotive preferred).
• 3 plus years of leadership experience with the ability to mentor, train, and drive performance.
• Strong communication skills, both written and verbal, with the ability to collaborate across departments.
• Experience managing and improving Quality Management Systems (ISO 13485 preferred).
• Hands-on approach to problem-solving, team leadership, and process improvement.
• Customer-facing experience, including handling complaints, RMAs, and audits.
• Experience leading internal audits and implementing corrective and preventive actions.
• Proficiency in MS Office and working knowledge of ERP/MRP systems.
• Ability to analyze quality data and use statistical tools for decision-making.
• Strong organizational skills with the ability to influence decisions and drive change.
• Experience facilitating customer and regulatory audits.
• Ability to build trust and credibility through ethical leadership and a culture-first mindset.
• Local to Somersworth, NH

Job Offer

• Leadership role in a growing, high-performance manufacturing environment.
• Opportunity to shape the quality function and drive cultural change.
• Strong collaboration with corporate leadership, providing visibility and career growth.
• Generous PTO starting at 200 hours.
• Minimal travel required (less than 5%).
• Stability within an established company with new corporate backing.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.