Quality Manager - Medical Device - Franklin, MA

Quality Strategy Leader

Lead the quality strategy for a growing medical manufacturing business. Own ISO 13485 compliance while driving impactful improvements.

Our client is a well-established manufacturer serving highly technical and regulated industries where quality, precision, and compliance are critical to success. They have built an excellent reputation for innovation, operational excellence, and delivering products that play an important role in customer applications worldwide.

Job Description

Provide strategic leadership for the company's Quality Management System while ensuring ongoing compliance with ISO standards and applicable regulatory requirements. Lead internal, customer, supplier, and third-party audits while maintaining audit readiness across the organization. Manage product inspection, testing, validation, and release activities to ensure compliance with quality specifications. Develop, mentor, and lead the quality team through coaching, training, and professional development initiatives. Drive investigations into non-conformances, customer complaints, and quality events, implementing effective corrective and preventive actions. Establish and monitor key quality metrics, providing meaningful analysis and recommendations to leadership. Partner closely with Manufacturing, Engineering, and Supply Chain teams to maintain and improve quality performance. Champion continuous improvement initiatives focused on process enhancement, risk reduction, and operational excellence. Ensure all products and processes meet applicable regulatory and customer requirements. Oversee supplier quality programs, including supplier qualification, auditing, and performance management.

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.

The Successful Applicant

Bachelor's degree in Engineering, Quality Management, or a related technical discipline. 5+ years of quality leadership or quality assurance experience within a regulated manufacturing environment. Demonstrated expertise with ISO 13485, FDA requirements, and medical device quality standards. Proven success leading audits, managing quality systems, and driving regulatory compliance initiatives. Strong analytical, problem-solving, and root cause investigation skills. Excellent leadership, communication, and stakeholder management capabilities. Experience using QMS, CAPA, and other quality management tools. Highly organized with a passion for continuous improvement and operational excellence.

What's on Offer

Opportunity to lead and shape the quality function of a growing organization. High-visibility role with direct impact on business performance and customer satisfaction. Collaborative environment with strong cross-functional engagement. Ability to influence continuous improvement and operational excellence initiatives. Work in a highly regulated industry where quality is mission-critical.

Job summary: Sector Engineering & Manufacturing, Sub Sector Quality, Technical. Industry Industrial / Manufacturing. Location Franklin. Contract Type Permanent. Consultant name Taylor Rankin. Job Reference JN-092026-7105529.