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QUALITY ASSURANCE ENGINEER - OFFALY
Company:ICDS RECRUITMENT |
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Job Reference Number |
14572020 |
Client ID: |
RI/AM12448 |
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Posted On: |
Feb 22 2012 |
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Location: |
OFFALY |
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Job Type: |
Permanent |
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Salary: |
NEGOTIABLE |
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SUMMARY DESCRIPTION
In this role you will proactively support engineering activities with regards to 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 delivered product quality and continuity of established QMS and to support growth of the Company.
ESSENTIAL DUTIES AND 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.
• Working with other sites, project manage for this 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, 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 executables to ensure smooth transition into established QMS at plant.
• Champion DFM and DFT approaches with the engineering group, aiming for Lean and 6 Sigma manufacturing.
• Working with Corporate Reliability department 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/EXPERIENCE REQUIRED:
• Ideally you will have a degree level qualification in Electronic Engineering.
• Minimum 2-5 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
• Ideally 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
• Ideally experience in internal auditing to QSRs
• Working familiarity with ISO 14971: 2007 and IEC 60601 an advantage
