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.
* Collaborate 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.
* Perform critical assessment of internal and supplier proposed change management activities.
* Perform PPAP and related activities for supplier changes.
* Participate 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 apply knowledge to manufacturing operations.
* Support the creation and maintenance of inspection methods and sampling.
* Apply 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.
Travel Percentage: None
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