Great Quality opportunity based in Tipperary to help run their Quality & Compliance on site
This company continually strive to develop complimentary product groups for all the market sectors that it services. Initially focused on the clinical diagnostic and food technology markets, the company has grown exponentially to become a market leading supplier across the Healthcare and Biotechnology sectors.
This role will work cross functionally with the other teams on site to ensure that the quality and compliance are maintained and improved and that the relevant standardisations (ISO 9001, ISO 13485 and GDP guidelines) are adhered to. This is a great opportunity for someone who enjoys leading from the front and working collaboratively with others.
The ideal candidate for this role will be comfortable with the following:
Job Role and Responsibilities:
- Implement, maintain and ensure compliance to the quality system application (ISO 9001, ISO 13485 and GDP Guidelines).
- 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.
- 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.
- 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
This is a key hire for the company I am working with and they are intent on moving quickly for the right individual. A pre-Christmas start would be ideal for them and they are very open to flexible working options.
If you would like to hear more about this opportunity or if you are interested in this role click the 'apply now' button below or get in touch on 021 2300 300.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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