Senior Technical Quality Engineer

Responsible of coordinating all the activities within the site Technical Quality function including supervising other quality engineers and technicians. The scope of the role is to provide support to operations within technical documentation, risk assessments, investigations, validation, metrology, calibration and continuous improvement. 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 determining 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/KPI's are cascaded, established, reviewed and discussed