Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description 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 Contribute to the development of less experienced staff by setting an example, providing guidance and work direction, and offering counsel • 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 Requirements/Qualifications: • 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 Company Benefits: Access to company stock purchase scheme Holiday purchase program Pension Scheme Medical Benefit Options Group Income Protection cover