Senior Quality Manager - Medical Device - Westwood, MA

The Senior Quality Manager, medical device manufacturing, will lead and manage the Quality Assurance and Control teams, overseeing the implementation and continuous improvement of the site's Quality Management System. They will work cross-functionally to ensure compliance with regulatory requirements, drive process improvements, and support new product development initiatives at our Westwood, MA location.

Client Details

My client is a leading provider of analytical instruments and services, specializing in delivering innovative solutions for industries such as biopharmaceuticals, clinical diagnostics, and food and beverage production. With nearly 70 years of experience, the company is committed to helping organizations improve quality, achieve reliable outcomes, and increase productivity through precision-engineered technologies and dedicated customer support.

Their product portfolio includes cutting-edge instruments designed for cell line development, liquid handling validation, osmolality testing, and other critical analytical applications. These solutions are supported by a robust suite of services, including instrument calibration, installation, and bioprocessing qualification, ensuring customers receive accurate and consistent results. The company also emphasizes user-centric design and technical expertise to address the most complex challenges faced by its clients.

Driven by a commitment to innovation and customer success, my client operates with a focus on service, quality, and reliability. Their core values of integrity, collaboration, and ingenuity underscore their approach to delivering impactful solutions that optimize processes and drive confident outcomes across the industries they serve.

Description

The Senior Quality Manager, Medical Device Manufacturing, will:

• Manage Quality Assurance (QA) and Quality Control (QC) teams to support organizational functions.
• Lead and maintain the site's Quality Management System (QMS), including CAPA, NCMR, complaints, audits, and management reviews.
• Coordinate QMS activities across global sites to ensure alignment and compliance.
• Collaborate cross-functionally on new product development, ensuring robust requirements, specifications, and test protocols.
• Review and support product and manufacturing process changes, focusing on risk management and design control compliance.
• Act as the organization's QMS expert, staying updated on evolving industry regulations and standards.
• Drive a culture of quality and continuous improvement throughout the organization.
• Oversee validation and verification processes to ensure compliance with internal and external requirements.
• Provide strategic input on quality initiatives to enhance operational excellence and product reliability.
• Ensure proper implementation and adherence to internal procedures and external regulatory standards.
• On site at our Westwood, MA facility - 4 days per week

Profile

• In-depth knowledge of ISO 13485, ISO 9001, FDA QSR, IVDR, and relevant product safety standards.
• 10+ years of quality systems experience, with a focus on medical devices and in vitro diagnostics (IVD).
• 5+ years of direct management experience, including team development and performance management ideally in a Quality Manager or Senior Quality Manager title.
• Expertise in managing ISO/MDSAP audits, customer audits, and regulatory inspections.
• Proficiency with electronic QMS software and business intelligence tools.
• Strong organizational, verbal, and written communication skills to lead and collaborate effectively.
• Local to Westwood, MA

Job Offer

• One day per week at home
• 3 weeks of vacation to start, increasing with tenure (up to 5 weeks)
• 72 hours of sick time and 11 holidays annually
• 401k plan with 40% company match (up to IRS limits) and full vesting after 1 year
• Health insurance plan with no deductible
• Tuition reimbursement up to $5,250 per year after 6 months
• Access to health & wellness benefits and comprehensive coverage options
• Professional development opportunities and support for career growth

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.