Strefa Klienta
For our client - international medical devices producer we are looking for a Senior Manager - QARA - EMEA provides leadership, direction and hands-on involvement with the Company's quality managements system in support of internal and external compliance standards, company objectives, and customer requirements.
What's on Offer
- The opportunity to gain experience in a global manufacturing company
- Attractive salary
- Work in an international environment
Job Description
- Serves as a liaison between Company/business partners and the national Competent Authorities (Ministries of Health)
- Assist with certain device registrations, as required
- Make a current copy of Technical File or CE Declaration of Conformity available for inspection by a Competent Authority, upon request
- Ensure compliance to applicable US FDA, Health Canada, EU Medical Device Regulations/Medical Device Directive, CFDA and other international country-specific requirements and policies
- Ensure currency and implementation of new and changing country and agency-specific regulations
- Manage inter-related global quality system compliance on all medical devices from concept through post-market activities; manage
- Integrate knowledge of the Quality Policy and Business Objectives into work practices to augment the business
- Participate in the preparation of internal and external audit program
- Develop responses to core quality system external and internal audits
- Perform quality reviews, audits, investigations, and CAPAs
- Perform supplier assessments, qualifications, and audits
- Maintaining and improving QMS processes, plans, and reviews
- Prepare charts and track quality metrics in support of quality planning for Management Review
- Coordinate training of all employees on procedures, policies or other quality related training programs
- Collaborate with global and regional QA/RA teams
The Successful Applicant
- University degree in science, engineering, business, management or similar
- Fluent English
- Extensive knowledge or certifications in US FDA Regulations, EU Medical Device Directive and Regulation
- Highly desirable knowledge in international regulations including Canada, Brazil, Australia, China, and Japan
- ASQ certification (e.g. Certified Quality Manager, Certified Quality Auditor, Certified Quality, Engineer)
- RAPS certification (e.g. US, Canada or EU)
- Experience in Quality Assurance and Regulatory Affairs for medical devices
- Experience as external auditor in the scope of medical devices
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