Our client is a leading distributer of Clinical, Pharmaceutical & Medical equipment & consumables. They are currently seeking a Quality Systems & Compliance Specialist to join an established team in their offices in Tipperary. This is a permanent full time role. The successful person shall report to the Director of operations. RP qualification is desirable, but not essential. Experience of Quality implementation & internal auditing from a distribution/ Medical device or Pharmaceutical background is essential.
o Implement, maintain and ensure compliance to the quality system application at our clients business (ISO 9001, ISO 13485 and GDP Guideline c2013/C 343/01).
o Identifies guidance documents, international standards, consensus standards and assists teams with their interpretation.
o Lead and Manage NCR, CAPA & Change Control process, ensuring all Quality related activities are completed in a timely manner.
o Manage Complaint/feedback/pharmacovigilance activities as required through Distribution Agreements and regulatory requirements in conjunction with the Sales Department and Suppliers.
o Review and maintain procedures, polices and other instructional documents with a focus on continuous improvement.
o Review and approval of protocols, reports, and change management documentation ensuring defendable practices and conclusions.
o Input and approval of validation/verification projects of equipment and processes.
o Administration of calibration and preventative maintenance logs and documentation, providing notification of scheduled calibrations, PMs and Services to relevant parties.
o Manage Risk Management processes. Manage the risk register and the opportunity register.
o Oversight of internal audit schedule and conduct of internal quality system audits. Perform supplier quality audits where needed.
o Organise, support and participate in external Audits (HPRA, Certification Body, Customer Audits)
o Co-ordination of annual management review, minute taking and manage out-coming actions.
o Level 8 degree qualification in a relevant Science, Engineering or Quality Assurance discipline
o 5+ years industry experience working in a Quality Assurance regulated medical product environment
o Thorough knowledge of MDD, MDR, IVDD, IVDR, ISO 9001, ISO13485, GDP Guideline c2013/C 343/01 and other international regulatory requirements.
o Fluent in English
o Proficient in Excel, PowerPoint, Visio, Word etc.
o Strong interpersonal skills and the ability to communicate well, both verbally and in writing & with others.
o Excellent attention to detail and ability to prioritise
If you would like further Information you can contact the recruiter directly:
Karen Shiel | Tel: +353 (0) 1 5079256