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 Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.