Regulatory Affairs and Quality Assurance Manager for medical devices

Cogmedix is a wholly owned subsidiary of The Coghlin Companies partnering with innovative companies to bring new medical and clinical product ideas to market.   Cogmedix will manufacture Class 1 and 2 medical and clinical devices and offers full worldwide shipping and fulfillment.  We are building best-in-class Quality Assurance and Regulatory Programs, seeking:

Regulatory Affairs and Quality Assurance Manager



Job Summary:  Reporting to the General Manager, the RA/QA Manager will develop, implement, and coordinate quality assurance and regulatory programs to assure compliance with Notified Bodies.  Responsible for integrity of all quality and regulatory programs.

 

Essential Functions:Design quality assurance program that assures compliance with all regulatory bodies (US FDA, Health Canada, ISO 13485 and European (MDD)) Work with senior management team to create, document, analyze, and improve company processes striving for increased efficiency, quality and reduced costs. Implement and enforce current, new, and revised company policies and procedures. Assist all staff with process engineering and continuous improvement efforts. Interface with Notified Bodies and outside consultants for both internal and external quality audits. Serve as the Management Representative to Notified Bodies. Manage response to all Corrective and Preventative Actions (CAPA’s) and Customer Inquiries and Complaints Analyze and report company data, including customer complaints and non-conformance reports (NCR’s), for patterns or trends.  Identify potential problems before they occur.  Relentless in the pursuit of continuous improvement across the organization. Expert identification of root causes of concerns and swift coordination of appropriate response. Coordinate training for policies and procedures, maintain training logs, documentation control system Maintain effective relationships with outside consultants and technical experts

 

Qualifications/Basic Job Requirements: BA/BS degree or equivalent in scientific or technical field 5+ years experience with an FDA regulated Medical Device Manufacturer a must, preferably in a fast-paced, flexible manufacturing environment Expert knowledge and experience with implementation and maintenance of an ISO 13485 and FDA cGMP Quality System Strong skills in technical writing, analysis, and proven effective verbal communications Certifications:  CQA or CQM History of effective interactions with Notified Bodies preferred




Cogmedix operations are based at our large manufacturing and engineering campus in Worcester, Massachusetts. Company benefits include shared medical insurance, life, LTD, dental, paid leave time, holidays, 401(k) plan, direct deposit, and a clean, pleasant working atmosphere.  Send resume to: nancyberkeley@columbiatech.com or to Nancy Berkeley, Human Resources Recruiter, Cogmedix, 17 Briden Street, Worcester, MA 01605. Coghlin is an equal opportunity employer.

Cogmedix - Incorporated in 2008 with a focus on Quality, Compassion and Compliance..