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 QA Engineer - New Projects will proactively support quality engineering activities with regards to New Product Introductions ensuring product quality, and compliance with requirements of global regulations. This is an essential function in the overall strategy for improved assurance of delivered product quality and continuity of established QMS and to support growth of the Company.
This is a permanent role based in The Midlands with excellent progression opportunities
Key Responsibilities of QA Engineer - New Projects:
- Key member of New Product Introduction teams, transfer and implement product and processes from development or from another manufacturing facility.
- Ensuing Design Output addresses all Design Input
- The New Product Introduction project is in compliance with all applicable Quality System Regulations, ISO Quality Standards, and all applicable external standards;
- Device Master Record (DMR) and manufacturing Standard Operating Procedure (SOP) documentation is complete and accurate;
- Suppliers of key materials defined in the DMR are identified, qualified and controlled;
- Reviews risk hazard analysis and D-FMEA updates on new product or product changes, mitigating risk and controlling compliance to Risk Management and cGMP requirements.
- Support P-FMEA activities with QA and or Process Engineering group.
- Review and approval of Change Request for New products or product changes.
- Provide technical support for new product transfers from other site facilities, writing Quality Plans, and monitoring status of executable to ensure smooth transition into established QMS at Tullamore.
- Ensure Regulatory compliance in area of responsibility to cGMP's of all medical device regulatory agencies
- Provide functional expertise to other support functions on quality related issues (e.g. regulatory requirements, statistical techniques, sampling principles).
- 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.
- Participates in external regulatory audits in areas of their responsibility.
- Carry out other tasks or responsibilities as directed by the Senior QA manager.
Requirements of the QA Engineer - New Projects:
? Engineer/Science qualification (Minimum BSc or BEng) with minimum of 3-5 years working within QA/RA 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 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.