Job Description:
Latest job information from Sanmina for the position of QA Engineer - Risk Management. If the QA Engineer - Risk Management vacancy in Cork matches your qualifications, please submit your latest application or CV directly through the updated Jobkos job portal.
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Job Description
JOB TITLE: QA Engineer - Risk Management DEPARTMENT:Quality Department REPORTING TO: Head of Quality About Sanmina Fermoy Our Fermoy, Ireland, facility is FDA registered and certified to ISO ISO for the manufacture of high-quality PCBAs, subassemblies and complete devices up to and including Class III medical devices. Sanmina Fermoys core specialization is manufacturing automation. We provide services for the entire product lifecycle from New Product Introduction (NPI), prototyping and process validation to complex volume manufacturing & test, shipping and repair. We create a state-of-the-art environment for manufacturing medical and other high-quality devices. The facility has a track record of 30 years of outstanding operational performance and customer service, backed by a highly experienced workforce. We hire people with a range of skills, experience, and backgrounds to fulfill roles in careers such as engineering, quality and manufacturing to name just a few. Objectives of Position The Risk & Event Lead ensures customer accounts utilize robust Risk Management and Event Investigation tools to drive continuous process improvement. This role serves as the principal interface for risk mitigation (PFMEA) and investigation alignment within Sanmina Ireland UC, ensuring strict adherence to FDA Quality System Regulations and international standards. Responsibilities Lead end-to-end Quality support for manufacturing, managing investigations into potential material and process non-conformances. Manage team to achieve best in class risk Mitigation approach and drive effective Event investigation process. Drive "live" PFMEA risk mitigation and closed-loop investigation processes to ensure site-wide compliance under change control. Generate and analyze Quality metrics using statistical tools to support risk mitigation across all sub-processes. Develop and approve SOPs, Quality Plans, FMEAs, and Control Plans. Support NPI and QSR Validation protocols (IQ/OQ/PQ) ensuring best-in-class risk planning. Conduct internal audits and participate in regulatory agency inspections regarding risk/event management rationales. Manage the Event Investigation Forum, monitoring weekly data and implementing problem-solving techniques. Ensure ongoing compliance with Health, Safety, and industry regulatory requirements. Conduct ISO 14971 Risk management training on site and provide mentorship as required. Quality: Assure ongoing compliance with quality and industry regulatory requirements. Health & Safety: Ensure compliance with Health & Safety Legislation and Regulations. Measurement Timely closure of Open EIFs (target TPBN1_IJ
Job Info:
- Company: Sanmina
- Position: QA Engineer - Risk Management
- Work Location: Cork
- Country: IE
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