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Quality Manager - US

Company: Corin
Location: Raynham
Posted on: July 31, 2022

Job Description:

Corin is seeking an experienced Quality Manager to drive the "Quality Culture" across our US sites (Raynham, Tampa and Milpitas) and ensure our Quality Management System (QMS) is compliant with national and international regulations.As our Quality Manager you will have the ability to motivate cross-functional team members at all levels of the company on all areas of quality and be flexible and adaptable to support and problem solve so we reach our Company goals. This role will be based in our Raynham, MA office and we are looking for a seasoned quality professional who has ideally worked in medical devices / orthopaedics with class 3 devices, or has worked in a highly regulated business within pharmaceutical, healthcare or clinical. The key responsibilities of a Quality Manager will manage the end-to-end complaint handling process for the US including complaint intake, triaging, investigations (as applicable), and final closure for Omni devices and will; Manage document control and training departments in accordance with local procedures and regulatory requirements. Manage the CAPA process to ensure timeliness and compliance in accordance with local procedures and regulatory requirements. Provide Raynham Metrics for Global presentation. Responds to and maintains communications with the Heath Authority or Notified bodies in case of Audit finding for Complaints process. Supports both FDA inspections and notified body audits, both pre and post activities and follow up. Responsible for the internal audit function, including issuing the annual internal audit schedule, scheduling audit resources, facilitating nonconformance investigations, and responding to findings. Support with eQMS integration and process harmonization Deputy Management Representative Update current procedures/processes or create new procedures/processes accordingly in USParticipateon project teams for purposes of identifying quality and regulatoryrequirements.Liaison with external parties on mattersrelating to the Quality System.Lead by example; maintain enthusiasm andmorale within department; maintain company-wide motivation of QualitySystems related activities. Lead by example; maintain enthusiasm and morale within department; maintain company-wide motivation of Quality Systems related activities.RequirementsThe ideal Quality Manager will have:BS degree in Engineering and/or science disciplineor equivalent experience.Seasoned Quality leader with 5-10 yearsof experience in Quality Assurance within medical devices industry (FDA 21CFR 820, ISO 13485, EU MDD, EU MDR).Global experience including knowledge ofUS and international regulations/GMP requirements, leading global teamsDemonstrated outstanding communicationand presentation skills to audiences with various levels of Qualityknowledge and expertiseDemonstrated ability to influence, and interacteffectively across a global organization, building effective relationshipsinternally and externally. Strong aptitude of Medical Device QMS andregulatory requirements including, but not limited to, ISO13485 and U.S.FDA 21CFR820 Strong/result-oriented experience inmanaging Health Authority inspections/ responsesOrthopedics and technology experience aplus Corin provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Keywords: Corin, Brockton , Quality Manager - US, Executive , Raynham, Massachusetts

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