Senior Quality Engineer

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