Quality Manager – Medical Device – Buffalo, NY Position Available In Erie, New York

Job Description:

My client is seeking a highly skilled Quality Manager to overseeday-to-day operations in their Buffalo, NY site. This site hasthree specific product lines and has just undertaken a new customerwhich has further increased performance. The role will have 10direct reports and sit on the leadership team for the plant. ClientDetails Our client is an end-to-end solution provider from designand development to finish device manufacturing and assembly. Theygo back almost five decades and have been strategically buildingour capabilities portfolio to offer their customers a complete,end-to-end solution for their medical device needs. Description TheQuality Manager will be responsible for: Lead and manage allaspects of the site’s Quality Management System (QMS) to ensurecompliance with applicable regulations and standards. Serve as thesite’s Management Representative for regulatory and customeraudits. Oversee quality assurance, quality control, incominginspection, document control, and CAPA systems. Ensure effectiveimplementation of ISO 13485 and FDA QSR requirements at the site.

Coordinate and host external audits (FDA, ISO, customer) and ensuretimely resolution of findings. Partner with Engineering,Operations, and Supply Chain to drive continuous improvement, riskmanagement, and product quality initiatives. Monitor key qualitymetrics and report on performance to senior leadership. Leadinvestigations into non-conformances, customer complaints, andsupplier quality issues; ensure timely and effective CAPA. Manageand mentor the site quality team, fostering professionaldevelopment and accountability. Oversee validation protocols andreports (IQ/OQ/PQ), ensuring appropriate quality input. Supportproduct transfers, process changes, and new product introductionsfrom a quality perspective. Profile The successful Quality Managerwill have: Bachelor’s degree in Engineering or a related field orRelated Work experience Heavy experience working in an ISOregulated environment (Medical Device, Automotive, Aerospacepreferred) Experience with risk management processes, processvalidation, and supplier quality management. Strong analytical andproblem-solving skills. Excellent communication and interpersonalskills. Strong Management experience (3 years) Job Offer My clientcan offer the following for the

Quality Manager:

Competitive BaseSalary Bonus Potential (Up to 12%) Over 136 hours of PTO 10Floating Holidays 401k Company Matching Program Opportunity to siton Leadership Team for Site

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All relevant applicantswill receive follow up within 72 hours of submission. MPI does notdiscriminate on the basis of race, color, religion, sex, sexualorientation, gender identity or expression, national origin, age,disability, veteran status, marital status, or based on anindividual’s status in any group or class protected by applicablefederal, state or local law. MPI encourages applications fromminorities, women, the disabled, protected veterans and all otherqualified applicants.