Description
I have an opening for a Senior Quality Engineer with a leading medical device company based in Co Offaly. This is an excellent opportunity to join a rapidly growing company in senior quality position. Candidates with a strong Quality Systems background are highly desired.Key role of this position is to proactively support engineering activities with regards to product robustness changes and compliance related projects, ensuring technical correctness, and compliance with requirements of global regulations.
RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:
* Working in conjunction with on-site and overseas based Engineering Departments, 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 Department, 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.
* Working with other site/s, project manage for exisiting site, QMS alignment to ensure compliance continuance to allow for duality of manufacture of product, as part of business risk mitigation initiative.
* 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, address the requirements of design inputs, and confirm these are linked 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 using recognized quality tools, on design / process 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.
* Provide P-FMEA update activities with QA and or Process Engineering group as part of change control.
* Provide technical support for new product transfers from other company facilities, writing Quality Plans, and monitoring status of executables 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 department to ensure products attain expected life expectancy aligned with market expectations, MTBF calculations, HALT / HASS, 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.
EXPERIENCE REQUIRED
* 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
* Degree level in electro-mechanical or technology engineering
* 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 essential.
* Experience in internal auditing to QSRs
* Working familiarity with ISO 14971: 2007 and IEC rd Ed a distinct advantage
If you are interested in hearing more about this fantastic opportunity please apply directly to this advert or contact Derek Sheridan on