Job Description
Senior Quality Engineer - 18 month Fixed Term Contract
Summary: Collaborate with operations, suppliers, and business functions to ensure quality performance of products and processes, and drive quality improvements in a dynamic environment.
As a Senior Quality Engineer, you will work closely with operations, suppliers, and business functions to ensure quality performance of products and processes. Your responsibilities will include:
- Collaborating with Divisional QA, cross-functional, and suppliers' teams to address top quality issues.
- Managing internal and supplier-driven non-conformances and ensuring timely closure of NC's within Trackwise.
- Leading internal CAPAs and managing to timely root cause investigation, implementation, and closure.
- Disposing non-conforming product within MRB, issuing NC's as appropriate.
- Communicating and collaborating with suppliers regarding non-conformances, escalating supplier corrective action requests as required.
- Engaging in the development and improvement of internal manufacturing processes for existing products.
- Performing critical assessments of internal and supplier-proposed change management activities.
- Performing PPAP and related activities for supplier changes.
- Participating in the creation and/or review of new or modified procedures.
- Maintaining KPIs for monitoring of process and/or product quality, performing analysis, and interpreting trends, identifying and activating on appropriate actions as necessary.
- Supporting execution and analysis of manufacturing-related complaints and product field actions.
- Supporting and driving Human Factor practices, familiarity in the science of Human Factor identification, reduction, and mitigation.
- Collaborating with stakeholders to identify and execute opportunities for supplier part certification.
- Developing understanding of risk management practices and concepts and applying knowledge to manufacturing operations.
- Supporting the creation and maintenance of inspection methods and sampling.
- Applying statistical methods of analysis and process control to current operations.
- Engaging and interfacing in internal and external audits providing subject matter expertise.
- Supporting the development and review of process and equipment validation/qualification and MSA of internal processes.
- Executing internal quality deliverables associated with engineering changes, manufacturing transfers, and supplier-initiated changes.
- Supporting 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.
This role would suit someone working in a quality engineering role or similar looking to progress their career. A Level 8 degree in Science, Engineering, or equivalent/related subject is required, along with a minimum of 2 or more years of experience. Experience in the Medical Device Industry, Validation, and NC and CAPA is highly advantageous.