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Change Control Specialist, Medical Devices
Bose Corporation
Framingham, MA, United States
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Maintain the company’s documentation related to the Quality Management System for Medical Devices (QMS-MD). Manage and execute all PCNs/ECNs, Standards Library, Files of Protocols and Reports, Supplier qualification files.
Responsible for QMS-MD records and corporate QMS-MD Procedures.
Aid in the development of Design History File (DHF) content, and coordinate document control activities within the emerging business group.
Coordinate activities related to the QMS-MD Engineering Change Notice (ECN) process.
Input and update BOMs.
Assist with procedure development and review, validation protocols, and similar documents necessary for the continued compliance of the quality system.
Maintain training log.
Support preparation for customer audits.
Occasional technical writing.
Assist staff with product testing, inquiries, customer complaints and support as needed.
Coordinate Corrective and Preventive action activities. Maintain all CAPA, NCMR, and Complaint Files.
Maintain HIPPA records related to clinical trials.
Performs other related duties of a similar nature and complexity as required.
ducation: Bachelor Degree required
Experience:Minimum 3 years experience required in documentation management for medical devices. Excellent grasp of medical device quality systems including FDA QSR and ISO 13485
Skills: Computer expertise with MS Office Suite. Excellent written and verbal communication skills.
Bose is an equal opportunity employer that is committed to inclusion and diversity. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or any other legally protected characteristics.
Bose is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the application or employment process, please send an e-mail and let us know the nature of your request and your contact information.