Senior Quality Engineer
Publication date:
17 October 2024Workload:
100%Contract type:
Unlimited employment- Place of work:Limerick
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 Industry
- Validation
- NC and CAPA