Quality Engineering Manager

Quality Engineering Manager
Location: Marlborough, MA
Industry: Medical Device

Overview:
A growing medical device organization is seeking a Quality Engineering Manager to lead quality engineering efforts related to the transfer and sustaining of manufacturing operations. The company develops advanced technologies aimed at improving patient outcomes, with a focus on high-performance devices used in clinical settings.

The Manager, Quality Engineering will lead quality engineering activities related to the transfer and sustaining of manufacturing operations. This role ensures compliance with global medical device regulations and standards, while providing quality oversight across design, manufacturing, and validation processes. The position offers cross-functional exposure and leadership responsibility within a fast-paced, innovation-driven environment.

Key Responsibilities:

• Lead and mentor the manufacturing quality engineering team.
• Manage direct reports and support professional development.
• Monitor and report on Manufacturing and Quality KPIs.
• Oversee design control activities for new and sustaining product development.
• Support risk management processes, including design and process FMEAs.
• Collaborate with supply chain and reliability teams to ensure quality outcomes.
• Participate in customer complaint investigations and reliability reviews.
• Oversee validation and verification activities, including software validation and IQ/OQ/PQ protocols.
• Support Manufacturing Engineering in maintaining DMRs, DHRs, BOMs, routers, and specifications.
• Prepare for and participate in internal and external audits.
• Contribute to continuous improvement of the Quality Management System (QMS).
• Perform additional duties as needed to support product and process quality.

Qualifications:

• Bachelor's degree in Engineering, Science, or a related technical field.
• 5-10 years of experience in medical device quality engineering, or 10-15 years of relevant experience.
• Strong knowledge of ISO 13485, FDA 21 CFR 820, and EU MDR / MDD.
• Experience with intravascular catheters and/or electro-mechanical medical devices.
• Familiarity with ISO 14971 risk management standards.
• Experience with sterile products and medical device software is highly desirable.
• Proven ability to manage multiple priorities in a fast-paced environment.