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
