Job Description:
QA Engineer
Location: Tullamore, County Offaly
Responsibilities:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:
- Working in conjunction with Engineering Department, co-develop design verification & validation protocols for new products (or transfer) and for change on existing products, conduct design verification & validation studies, review and approve protocols, studies, and perform general oversight responsibilities for validation process, for both equipment and processes.
- Key member of New Product Introduction teams, both working in conjunction with Product Development and Engineering Depts, for process and product understanding and technical assessment.
- Member of Engineering Peer Review of design approach, layouts, worst case best case analysis, tolerance stack-up, design architecture, regulatory compliance, and assessing supporting documentation.
- Approve alternate components, assuring compliance with relevant product safety files, and International regulatory / material usage requirements.
- Review Engineer’s Log Books for technical completeness, accuracy, and address of identified design inputs with associated demonstrable outputs.
- 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.
- Review MDHA and D-FMEA updates with RC / RA Dept., 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
- Provide technical support for new product transfers from other facilities, writing Quality Plans, and monitoring status of executable to ensure smooth transition into established QMS .
- Champion DFM and DFT approaches with the engineering group, aiming for Lean and 6 Sigma manufacturing.
- Working with Corp Reliability dept. to ensure products attain expected life expectancy aligned with market expectations, MTBF calculations and published data.
- Ensure that requirements laid down in the Quality Manual and Standard Operating Procedures are adhered too, and provide advice and guidance on quality related aspects.
- Conduct Internal Audits against schedule as part of Audit Team.
- Work closely with QA/RA Manager to effect roll-out of new Quality Initiatives and Corporate SOPs.
QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
- Degree level in Electronics Engineering.
- Minimum 3-5 years’ experience at Quality Engineering level within a FDA or ISO 13485 cGMP regulated medical device manufacturer, preferably in electronics or electro-mechanical based devices
- Excellent working knowledge of ISO 13485 and 21CFR820, along with exposure to other foreign Regs
- Hands-on experience with product and process validation protocols and studies
- Experience in internal auditing to QSRs
- Working familiarity with ISO 14971: 2007 and IEC 60601 a distinct advantage
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Pharmaceutical, QA engineer, engineering, production development, process engineering, technical support, quality planning, QMS, internal audits, quality initiatives, electronics engineering, quality engineering, ISO 13485, 21CFR820, ISO 14971, IEC 60601.
