Senior Technical Quality Engineer

Thermo Fisher Scientific


Date: 2 weeks ago
City: Newport
Contract type: Full time
Work Schedule

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

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

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