MCS Group is delighted to be exclusively partnering with CIGA Healthcare to recruit a QA Specialist (Medical Device/IVD), for their team in Ballymena as a result of business growth. We are seeking to recruit a QA specialist with experience in the Medical and In Vitro Diagnostic Device areas.
Our client is a well-established organisation, who have enjoyed rapid expansion throughout the years. As a result of further development and increased demand for their products, they are now seeking to add a QA Specialist to their busy, talented QA team.
In this role you will:
- Compile materials for license renewals, updates, and registrations.
- Maintain related QA files, databases, and chronologies adhering to change control procedures.
- Review technical documentation and labelling for compliance with quality and regulatory requirements.
- Create, modify, and review new and existing processes.
- Maintain your current knowledge of CE/ FDA and international regulation, guidance, and standards applicable to company products, e.g., MDD, IVD, MDR, IVDR, ISO 13485:2016, ISO 14971 etc.
- Actively participate in the evaluation of quality compliance of documents, products, processes, and test methods.
- Liaise with suppliers and sub-contract manufactures regarding QA issues.
- Maintain product EU technical files.
- Review advertising and marketing material for appropriateness and compliance to regulatory requirements and laws.
- Post-market surveillance planning and follow-up activities.
- Play an active role in both internal and external audits.
- Be an integral QA team member in maintaining the company's internal procedures, SOP's and ISO13485:2016 certification.
- Work with managers and staff to develop and execute QA strategies to meet and exceed customer and company goals.
The successful candidate:
- Degree in Engineering / Biological or Other Relevant Science or equivalent work experience.
- Relevant experience in a design and/or manufacturing QA role obtained in a Medical Device or In Vitro Diagnostic Device professional or OTC environment.
- Current working knowledge of ISO 14971, and ISO 13485:2016 as well as European regulations for Medical and In Vitro Diagnostic devices.
- Experience in compiling and maintaining CE technical files and maintaining production-related records.
- Proficient with MS office suite of products.
To speak in absolute confidence about this opportunity please send an up to date CV via the link provided or contact Kirsty Dillon Specialist Consultant at MCS Group 028 9693 5510
Even if this position is not right for you, we may have others that are. Please visit MCS Group to view a wide selection of our current jobs www.mcsgroup.jobs
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Experience: 0 yrs