Job Description
You will be responsible for all medical device product release activities to ensure that products are manufactured and released in accordance with regulatory requirements and the principles and guidelines of current Good Manufacturing Practices and Good Documentation Practices.
Responsibilities:
The in-process and final release of medical device products from contract manufacturing organisations (CMOs) for E.U. and international markets including manufacturing, inspection, packaging, and labeling batch records to ensure compliance.
Generation of associated product release certificates, archiving of electronic and hard copy batch documentation.
Subject matter expert for medical device product release processes
Responsible for ensuring all appropriate CMO batch related documents are available, and all documentation issues including queries, deviations, change controls, out of specification investigations and CAPAs are closed to enable release of products in a timely manner.
Communication with cross functional team and CMOs to align on product release timelines and resolve batch record issues.
Actively participate in project meetings as required.
Support medical device complaint investigations including batch record reviews
Develop, maintain and report quality system metrics relating to medical device product release activities as required.
Ensure that the documentation systems to support Device Quality are maintained.
Prepare and/or update standard operating procedures, device master records, and product specifications.
Review master batch records from contract manufacturers as required.
Support setup of medical device release processes for new product launches.
Education & Experience Requirements
University degree or equivalent in Science, Engineering or an equivalent technical discipline.
At least 3 years' experience in a Quality role working with medical device/in-vitro diagnostics/ combination products in a regulated healthcare industry.
Good understanding of E.U., U.S. and international medical device regulations and standards including ISO 13485, ISO 14971, E.U.
Medical Device Directive (MDD) and relevant CFRs Experience with deviations, nonconformances, out of specification investigations and CAPA Experience with SAP, Trackwise or similar systems
Prior experience in a product release role
Escalate potential delays to medical device product release timelines to Device QA Lead.
Communicate effectively with CMOs and assess information provided
For further information on this QA Specialist Medical Devices position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Laurentina@rftgroup.ie. Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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