Quality Manager - Medical Device Manufacturing - Marlborough

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!

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.