|Quality Assurance and Regulatory Affairs Manager||Dublin North||Not Disclosed|
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Quality Manager Career Profile
This is a wide role which often requires a Medical Device Quality Systems background and expertise within ISO 13485. Applyling this knowledge to a cutting edge industry is often an attraction for candidates who are used to working in a more manufacturing-orientated environment. A sample spec is below:
- Initially as a core member of the team which will implement a Global Quality Management System,
- As required oversee the production of DHF for products to be marketed in the US.
- As required assist in the preparation of 510k submissions for our client's products and product components. This may also require some involvement in clinical trials.
- As required develop an understanding of other overseas regulatory requirements (and prepare for submissions where clearance is required.
- Proactively develop and maintain the Company Quality Management System in accordance with regulatory and corporate requirements.
- Furthermore seek to improve the efficiency and effectiveness of the Quality System to meet the business strategy of the company.
- Act as the company representative in any company inspections/audits.
- Under the direction of the Head of RA/QA take ownership for the co-ordination of specific
- projects providing specific regulatory and quality services.
- Oversee design control for specific company products: review and approval of documents,
- maintain design history file, communicate findings and suggestion for improvements to design group. Ensure documents are produced in accordance with company procedures and check all documents for consistency and accuracy prior to issue.
- Work with service/manufacturing to ensure adequate quality controls prior to shipping.
Qualifications / Experience
- Degree level qualification preferred or an equivalent combination of education and experience to operate at this level.
- Proven RA / QA experience supporting product design control, customer support and production with at strong supervisory experience.
- Working knowledge of FDA Quality Systems Regulations and ISO 13485:2003 required.
- Internal audit qualification also preferred. ISO13485 lead auditor qualification preferred but not essential.
- Experience in medical devices
Understanding of QA and Regulatory requirements