Quality and Compliance Specialist - Co. Tipperary
An experienced Quality and Compliance Specialist is required basis for a client of mine who specialise in a range of Clinical quality control equipment as well as a range of medical devices.
Job Role and Responsibilities:
Implement, maintain and ensure compliance to the quality system application within their distribution business (ISO 9001, ISO 13485 and GDP Guideline c2013/C 343/01).
Identifies guidance documents, international standards, consensus standards and assists teams with their interpretation.
Lead and Manage NCR, CAPA & Change Control process, ensuring all Quality related activities are completed in a timely manner.
Manage Complaint/feedback/pharmacovigilance activities as required through Distribution Agreements and regulatory requirements in conjunction with the Sales Department and Suppliers.
Review and maintain procedures, polices and other instructional documents with a focus on continuous improvement.
Review and approval of protocols, reports, and change management documentation ensuring defendable practices and conclusions.
Input and approval of validation/verification projects of equipment and processes.
Administration of calibration and preventative maintenance logs and documentation, providing notification of scheduled calibrations, PMs and Services to relevant parties.
Manage Risk Management processes. Manage the risk register and the opportunity register.
Oversight of internal audit schedule and conduct of internal quality system audits. Perform supplier quality audits where needed.
Organise, support and participate in external Audits (HPRA, Certification Body, Customer Audits)
Co-ordination of annual management review, minute taking and manage out-coming actions.
Level 8 degree qualification in a relevant Science, Engineering or Quality Assurance discipline
5+ years industry experience working in a Quality Assurance regulated medical product environment
Thorough knowledge of MDD, MDR, IVDD, IVDR, ISO 9001, ISO13485, GDP Guideline c2013/C 343/01 and other international regulatory requirements.
Fluent in English
Proficient in Excel, PowerPoint, Visio, Word etc.
Strong interpersonal skills and the ability to communicate well, both verbally and in writing, with others.
Excellent attention to detail and ability to prioritise