Quality Engineer

FRS Recruitment

Limerick

A fantastic opportunity has arisen for a Quality Engineer to join a large multinational medical device company based in Limerick. This is a highly sought after company in Limerick and is a market leader within the medical device field offering an attractive salary, benefits and excellent career progression. This role is made for an experienced Quality Engineer that has worked in a similar industry and who wants to grow their career. They are a great company and it is a great place to work. They feel that their employees play a vital role in ensuring their success. They seek to be a leader in the markets that they serve. To ensure they get the right person for this role, to achieve their goals, they offer an excellent benefits program. They reflect their partnership with their employees to help protect them and their families from the high cost of healthcare, to provide disability income protection, and to help build financial security for their future and retirement. Reporting to the Senior Quality Engineer the primary function of this role is to provide Quality Engineering support to Manufacturing Engineering, Production, Quality Control, Product Development and Product Transfers. This includes, but is not limited to, providing support to process validation, change requests, non-conforming product issues, Corrective and Preventive Action program, Design and Process FMEA, risk assessment and associated Quality System Documentation. Responsibilities: Understand and review Validation documentation, Change Requests, Design and Process FMEA's, Test Summaries and Critical System Work Orders. Work as an integral part of the Product Transfer Team including support to the process/product being transferred from a technical and quality viewpoint and to understand and define the Process FMEA and Process Validation Requirements (including OQ / PQ / PPQ) for the transferred process. Provide Quality Engineering support through the entire Product Development process up to and including transfer to Production, understanding Design Assurance activities, reviewing associated documents including Design Verification/Design Validation, Design and Process FMEA, Process Validation and Test Summaries. Support the Vendor Appraisal and Approval processes. Support, maintain and develop the Process Validation program. Liaise with Quality Control by providing Quality Engineering support to Incoming Quality Control, In-Process and Final Quality Control. Provide input and support to the Corrective and Preventive Action program (CAPAs) and the Non-Conforming Product Process. Support of the Internal Audit, Vendor Audit and Regulatory Audit Programmes. Conducting and documenting complaint investigation. Investigates complaints and provide the results for the regulatory reporting process. Risk assessment of customer complaints, Non-conformance and CAPA's. Provide meaningful Quality measurement while ensuring that in-house or external Quality issues are effectively prioritised and acted upon in a timely manner. Qualifications/Requirements: Third Level qualification in Science, Engineering or a relevant technical discipline. Qualification in Quality/Validation/Statistics would be a distinct advantage. Proven knowledge and experience (ideally minimum 4 years) of working with ISO13485, ISO14971, the Medical Device Directive and the FDA QSR including 21 CFR Part 820 and 21 CFR Part 11, ideally gained in the medical device industry. Proven knowledge and experience of all aspects of Validation including Process Validation and Software Validation. Experience in packaging processes and associated regulatory requirements would be an advantage. For more information please do not hesitate to contact Teresa Tyler on 061 319 108 or 086 9348. This job originally appeared on RecruitIreland.com.

2795 days ago