Due to continued expansion of their operations our client a well-established Multinational Healthcare Manufacturer now require a qualified and experienced Senior QA Engineer.
The Senior QA Engineer will support quality engineering activities with regards to the Quality Management System, product robustness changes and compliance related projects, ensuring technical correctness, and compliance with requirements of global regulations. This is an essential function in the overall strategy for improved assurance of continuity and improvement of the established QMS, delivered product quality and to support growth of the Company.
This is a permanent role based in The Midlands with excellent progression opportunities
Key Responsibilities of Senior QA Engineer:
- Provide active management of the supporting elements of the Quality Management system.
- CAPA Management, management of the CAPA program and support Engineering and Manufacturing teams and lead CAPA investigations as required.
- Experience with Document Control system, internal audit programs, nonconformity systems and supplier management elements of the Quality Management system.
- Ensure Regulatory compliance in area of responsibility to cGMP?s of all medical device regulatory agencies.
- Drive and implement plant wide quality system improvements.
- Provide functional expertise to other support functions on quality related issues (e.g. regulatory requirements, statistical techniques, sampling principles).
- Takes a leadership role in developing and implementing new techniques and initiatives to enhance the Quality management system on site and across the Corporation where relevant.
- Collate and trend quality data relating to product robustness, conduct analysis and recommend necessary technical solutions to drive effective corrective action.
- Conduct detailed root cause analysis on design related non conformances, developing effective preventive measures to prevent recurrence.
- Approval of change requests for product, process and quality system changes.
- Conduct Internal Audits against schedule as part of Audit Team.
- Participates in external regulatory audits in areas of their responsibility.
? Engineer/Science qualification (Minimum BSc or BEng) with minimum of 5 years working within QA in a multi-national medical devices manufacturing environment.
? Excellent working knowledge of ISO 13485 and 21CFR820, along with exposure to other regulations. Working familiarity with IEC 60601 a distinct advantage.
? Experience in leading CAPA program, and other quality management systems and experience with leading and participating in several projects concurrently.
? Ability to accurately scope projects and consider the full impact of decisions and actions taken.
Please send an up to date CV and cover letter to John Reid at The RFT Group / firstname.lastname@example.org / on 01-2302400 / www.rftgroup.ie
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The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.