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Leica Biosystems
,
Newcastle upon Tyne, Tyne and Wear
QA Manager
Overview
Job Description
We're looking for a QA Manager to support our growing team at Leica Biosystems in Newcastle. This is a professional position with responsibilities for elements of the site quality management system. Responsibilities will include the management of Quality Systems, Design Quality and Supplier Quality. The QA Manager is experienced in multiple areas of medical device quality assurance and can apply that experience and in-depth knowledge. Serves as a resource for colleagues with less experience. May lead projects with manageable risks and resource requirements. Ability to tackle sophisticated problems affecting the quality system. Shares information and experience across LBS and Danaher sites. May serve as representative on task forces, councils or improvement initiatives. In this role you'll * Supervisory responsibilities for four QA professionals covering Design Quality, Supplier Quality and Quality Management. Set priorities and coordinates resources to meet priorities. * Responsible for planning, coordinating and conducting duties related to the Quality Systems, Supplier Quality and Design Quality * Utilize knowledge and experience to identify, tackle and document problems and risks within the quality system. * Serve as a resource and mentor to colleagues with less experience, including QA Officers. * Use Danaher Business System (DBS) tools on a regular basis to continually improve the QA function. * Work closely with QRA management in developing quality objectives. * Establish and maintain positive relationships with internal and external partners. * Maintain solid understanding of relevant regulations and quality system requirements that affect the business. * Other duties as assigned by management. What you'll need to do the job * Degree in science, medical or technical field and experience with growing responsibility in medical device Quality Assurance. * Quality management experience with medical devices or pharmaceuticals. * Ability to manage and develop a small team of quality management professionals * IVD medical device regulatory affairs experience a distinct advantage * Experience in conducting and hosting quality system audits/regulatory inspections. Experience with the MDSAP programme. * Solid understanding of international IVD medical device quality systems including but not limited to 21 CFR 820 and ISO 13485. * Experience in IVD medical device NPD, design controls and risk management * Experience in supplier quality, IVD reagent manufacturing, design transfer processes Interested? Join the Leica Bio Systems Team! Want to join our growing team that is helping our customers do incredible work? We look forward to your application! Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The "EEO is the Law" poster is available here.