Senior Technical Quality Engineer
Company
Location
Newport, Wales, United Kingdom
Posted At
3/21/2025
Advertise with us by contacting: [email protected]
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Description
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Key Responsibilities:
Standard (Mon-Fri)
Environmental Conditions
Office
Key Responsibilities:
- Lead the Technical Quality department including coordination of resources and prioritization of tasks
- Lead the development of risk management plans and risk management activities
- Lead to ensure support of transfer activities including new equipment qualification
- Support investigations and root cause analysis for complex problems
- Support customer complaint evaluations and corrective actions
- Provide Quality support for Calibration, Metrology, and Preventative Maintenance Systems
- Provide Quality support for Infrastructure changes (e.g. facility, cleanroom, environmental monitoring)
- Provide support within data analysis and statistically rationale and sampling plans
- Lead continuously improvement via PPI and/or CAPA processes
- Ensure timely resolution of customer complaints, supplier failure, corrective actions and preventive actions
- Promote continuous improvement within the department and provide support to other functions in improvement activities
- Author, review and execute IQ, OQ, PQ, TMV, and MVP for new equipment and when changing existing manufacturing process or equipment
- Drive improvement and efficiency initiatives to reduce process variation, and reduce/eliminate the cause of defects
- Support site Internal Audit program
- Exercise judgment in selecting innovative, practical methods to achieve problem resolution
- Participate in developing goals and objectives for projects
- Consistently promote high standards through personal example and roll out through the team so that each member of the team understands the standards and behaviors expected
- Ensure department objectives are cascaded, established, reviewed and discussed
- Bachelor's degree in engineering required plus 5-7 years of related work experience with a strong understanding of specified functional area, or an equivalent combination of education and work experience. Advanced degree preferred.
- 2+ years of commercial medical manufacturing in an engineering capacity
- Experience providing effective work direction to less experience engineers and technicians
- Working experience with ISO 9001 / 13485 and In vitro Diagnostics Regulation (IVDR)
- Relevant working experience with the implementation and application of ISO 14971
- Strong experience of PPI (Process Improvement methodologies – Lean/Six Sigma)
- Working experience with statistical techniques and data analysis software (example: Minitab, JMP, etc.)
- Ability to understand and interpret specification and use as a basis for routine decision making and actions
- Good organization skills to plan staff workloads and ongoing resources
- People management skills to ensure an impactful, efficient team with focus on job satisfaction and people development
- Desired certifications include CQE, PMP, and/or medical device auditor training
- Wide application of technical principles, practices, and procedures
- Excellent communication and team-building skills
- Access to company stock purchase scheme
- Holiday purchase program
- Pension Scheme
- Medical Benefit Options
- Group Income Protection cover
Advertise with us by contacting: [email protected]
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