Quality Manager - Medical Device - Buffalo, NY

Location: Buffalo
Posted on: June 23, 2025

Job Description:

My client is seeking a highly skilled Quality Manager to oversee day-to-day operations in their Buffalo, NY site. This site has three specific product lines and has just undertaken a new customer which has further increased performance. The role will have 10 direct reports and sit on the leadership team for the plant. Client Details Our client is an end-to-end solution provider from design and development to finish device manufacturing and assembly. They go back almost five decades and have been strategically building our capabilities portfolio to offer their customers a complete, end-to-end solution for their medical device needs. Description The Quality Manager will be responsible for: Lead and manage all aspects of the site's Quality Management System (QMS) to ensure compliance with applicable regulations and standards. Serve as the site's Management Representative for regulatory and customer audits. Oversee quality assurance, quality control, incoming inspection, document control, and CAPA systems. Ensure effective implementation of ISO 13485 and FDA QSR requirements at the site. Coordinate and host external audits (FDA, ISO, customer) and ensure timely resolution of findings. Partner with Engineering, Operations, and Supply Chain to drive continuous improvement, risk management, and product quality initiatives. Monitor key quality metrics and report on performance to senior leadership. Lead investigations into non-conformances, customer complaints, and supplier quality issues; ensure timely and effective CAPA. Manage and mentor the site quality team, fostering professional development and accountability. Oversee validation protocols and reports (IQ/OQ/PQ), ensuring appropriate quality input. Support product transfers, process changes, and new product introductions from a quality perspective. Profile The successful Quality Manager will have: Bachelor's degree in Engineering or a related field or Related Work experience Heavy experience working in an ISO regulated environment (Medical Device, Automotive, Aerospace preferred) Experience with risk management processes, process validation, and supplier quality management. Strong analytical and problem-solving skills. Excellent communication and interpersonal skills. Strong Management experience (3 years) Job Offer My client can offer the following for the Quality Manager: Competitive Base Salary Bonus Potential (Up to 12%) Over 136 hours of PTO 10 Floating Holidays 401k Company Matching Program Opportunity to sit on Leadership Team for Site APPLY TODAY! All relevant applicants will receive follow up within 72 hours of submission. 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.

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