Randstad Quality Assurance Coordinator in Framingham, Massachusetts
Quality Assurance Coordinator
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salary:$1 per year
date posted:Tuesday, October 10, 2017
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Randstad Sourceright, in partnership with the Bose Corporation, is seeking a Quality Assurance Coordinator, for a Perm role in Framingham, MA.
1) Maintain the company's documentation related to the Quality Management System for Medical Devices (QMS-MD). Manage all and execute all PCNs/ECNs, Standards Library, Files of Protocols and Reports, Supplier qualification files.
3) Aid in the development of Design History File (DHF) content, and coordinate document control activities within the emerging business group.
4) Responsible for QMS-MD records and corporate QMS-MD Procedures.
5) Coordinate activities related to the QMS-MD Engineering Change Notice (ECN) process.
6) Input and update BOMs
7) Maintain training log
8) Support preparation for customer audits.
9) Occasional Technical writing
10) Assist with procedure development and review, validation protocols and similar documents necessary for the continued compliance of the quality system.
11) Assist staff with product testing, inquiries, customer complaints and support as needed
12) Coordinate Corrective and Preventive action activities. Maintain all CAPA, NCMR, and Complaint Files
13) Performs other related duties of a similar nature and complexity as required.
Working hours: Standard
Minimum 3 years experience required in documentation management for medical devices required. Experience in quality assurance or medical devices preferred required.
Excellent grasp of medical device quality systems including FDA QSR and ISO 13485
Computer expertise with MS Office Suite, excellent written and verbal communication skills.
Familiarity with the requirements of Medical Devices and or other regulated environments a plus required.
Requires ability to interface with internal and external personnel.
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