Description
Senior Quality Engineer (UK-Bridgend, CAPA, Regulatory Affairs, Clinical Diagnostics)Bridgend, Wales, Vereinigtes Königreich Full-time Allows remote
We are currently looking for a motivated and experienced Senior Quality Engineer to join us for the next 12 months in Bridgend (United Kingdom), to analyzing and trending available data and using Process Excellence-tools and risk based and/or data driven decision making to drive improvements. Also ensuring that the validated state of the assigned Work Centre is maintained.
Tasks and responsibilities:
- Accountable for the preparation and issuance of Validation Plans, Protocols, Summary Reports and associated documentation for complex projects such as installation of new plant equipment, or significant supplier change.
- Provide root cause investigation and CAPA support for work centre. Including identification and execution of Corrective Action, Preventive Action and Effectiveness monitoring plans.
- Development of sampling plans based on statistically sound rationale for use in testing for Validation, Disposition and Effectiveness monitoring activities.
- Use risk based/data driven decision making to disposition non-conforming product. Understanding the needs of the customer, the clinical implications of the risk and the regulatory requirements. Developing strategies for complex disposition requirements.
- Support project teams and provide the face of quality in terms of validation and quality requirements.
- Use innovative thinking to drive simplifications to the quality processes with no impact to compliance. Identify and lead improvements, which have impact within and outside of QE.
Requirements:
- At least several years of experience and educations in Quality Engineering or in similar position with a proven track record of leading projects in regulated environment (pharma and chemical industry background is an advantage)
- Proven, well-developed quality, regulatory and compliance experience in a highly regulated manufacturing environment (e.g. pharma, chemise, clinical diagnostics)
- Experience in Validation of Equipment, Product, and Process
- Lean management Six Sigma understanding incl. use of tools in everyday decision making
- Ability to prioritize and manage risk. Demonstration of risk based decision making within product release or CIP/project background
- Excellent English communication skills (written and oral)
- Experienced working in multinational teams, i.e. sensitive of cultural differences and adaptable
- Experienced working in a global setup, i.e. comfortable with video conferences and remote work
Desirable: Experience working in medical diagnostics, Green / Black belt training, data analysis using Minitab