Quality Manager - Medical Device Manufacturing - Marlborough

The Quality Manager, medical device manufacturing, will lead the maintenance and continuous improvement of the quality management system to ensure compliance with regulatory standards and internal requirements at our Marlborough facility. They will oversee supplier quality, incoming inspection, and production support to drive consistency in product and process quality across the organization.

Client Details

My client is a medical technology company that designs and manufactures advanced imaging systems used in vision care. Originally founded with a mission rooted in personal experience, the company set out to solve a critical gap in diagnostic capabilities-providing clinicians with a more comprehensive view of the eye in a single, patient-friendly scan. Since then, their technology has become an important part of eye exams across a wide range of clinical settings. They are based out of Marlborough, MA.

Description

The Quality Manager, Medical Device Manufacturing will:

• Ensure compliance with cGMP, FDA, ISO 13485, and CFR Part 11 across all quality processes and documentation.
• Oversee the electronic quality management system (eQMS), ensuring full utilization and regulatory alignment.
• Manage internal and external audits, CAPAs, complaint handling, MDRs, and recall readiness.
• Maintain and improve procedures for configuration management, including change control, validation, and rollout planning.
• Supervise supplier quality, incoming inspection, and calibration activities, ensuring accurate records and effective controls.
• Maintain quality records including the Device Master Record, labelling files, and training documentation.
• Analyze production and field data to identify trends, drive corrective actions, and support continuous improvement.
• Lead continuous improvement initiatives to reduce defects and enhance product quality and process consistency.
• Collaborate with Manufacturing, Field Service, and Engineering to improve reliability and performance of installed devices.
• Track and report on quality metrics, audit outcomes, and customer feedback to inform quality initiatives.
• Promote quality and regulatory awareness through training and cross-functional engagement.
• Lead and develop Quality team members, fostering a high-performance and collaborative environment.
• Be onsite at our Marlborough, MA facility

Apply today for consideration of your application within 48 business hours!

Profile

• Strong leadership and team development experience
• Hands-on experience managing audits (FDA a plus, but ISO 9001 acceptable)
• Self-starter, autonomous, proactive in setting direction and driving improvement
• Comfortable working in a lean team-wearing multiple hats
• Experienced in using quality tools (RCA, 5 Whys, CAPA)

• Experience in a Quality role within a medical device or IVD manufacturing environment
• Proficiency with electronic quality management systems (eQMS)
• Qualified and experienced internal auditor
• Previous experience as a Quality Manager is a plus
• Strong understanding of ISO 13485, ISO 9001, QSR, and cGMP regulations
• Familiarity with FDA and MHRA quality systems and regulatory expectations
• Working knowledge of Quality System Regulations and global compliance standards
• Exposure to quality practices in a supply chain or manufacturing context
• Experience supporting regulatory audits and inspections
• Strong interpersonal and influencing skills across functions
• Detail-oriented with a proactive approach to problem-solving
• Solid computer literacy, including Microsoft Office application
• Ability to work effectively in a regulated, fast-paced environment
• Local to Marlborough, MA

Job Offer

• Competitive salary and comprehensive benefits package, including top-tier health, dental, and vision coverage.
• Hybrid flexibility once onboarded
• Long employee tenure
• Cutting edge technology
• Generous vacation, sick time, and 12 paid holidays.
• Opportunities for professional growth and career advancement in a dynamic, fast-paced environment.
• Access to cutting-edge technologies and the chance to work on innovative projects that impact global healthcare.
• A supportive, collaborative team culture focused on people-first values.
• Regular company events and team-building activities, including weekly food trucks.
• A chance to make a real difference by contributing to a company that helps save sight and lives.
• A stimulating, ever-evolving work environment that encourages personal and professional development.

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.