Senior Quality Engineer

4 days ago

Limerick, Ireland Howmedica International SdeRL Full time
Work Flexibility: Onsite

Senior Quality Engineer - This is an 18 month Fixed Term Contract

What You'll Do:

Work closely with operations, suppliers and the business functions to ensure quality performance of product and processes. Collaborates with Divisional QA, cross-functional and suppliers’ teams to address top quality issues. Own identified internal and supplier driven non-conformances and manage the timely closure of NC's within Trackwise. Own or support identified internal CAPAs and manage to timely root cause investigation, implementation and closure. Disposition non-conforming product within MRB, issuing NC's as appropriate. Communicate & collaborate with suppliers regarding non-conformances, escalating supplier corrective action requests as required. Engage in the development and improvement of the internal manufacturing processes for existing products. Performs critical assessment of internal and supplier proposed change management activities. Performs PPAP and related activities for supplier changes Participates and may lead in the creation and/or review of new or modified procedures.  Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary. Support execution and analysis of manufacturing related complaints and product field actions. Support and Drive Human Factor practices, familiarity in the science of Human Factor identification, reduction, and mitigation. Collaborate with appropriate stakeholders to identify and execute opportunities for supplier part certification.  Develop understanding of risk management practices and concepts and applies knowledge to manufacturing operations. Support the creation and maintenance of inspection methods and sampling. Applies statistical methods of analysis and process control to current operations. Engage and interface in internal and external audits providing subject matter expertise Support the development and review of process and equipment validation/qualification and MSA of internal processes. Execute internal quality deliverables associated with engineering changes, manufacturing transfers and supplier-initiated changes.  Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities. Responsible for initiation, internal containment, communication and support of Commercial Holds for potential product escapes.

What You'll Need:

This job would suit someone working in a quality engineering role or similar looking to progress their career Level 8 degree in Science, Engineering or equivalent/ related subject Minimum of 2 or more years experience Experience in the following is highly advantageous:Medical Device IndustryValidationNC and CAPA Travel Percentage: None

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