Operations Quality Team Manager

As an Operations Quality Team Manager, you will lead Q&R activities in the system plant as a PQE team manager. You will be responsible for driving product quality improvements by leveraging statistics and data analysis techniques to enhance processes. Your role will involve close collaboration with production, manufacturing engineering, and suppliers to ensure process control, quality assurance, effective failure analysis, and continuous improvement.
Your role:
Provide clear vision and strategy for the PQE team, ensuring alignment with organizational quality goals.
Build and develop the capabilities of the quality team, fostering a culture of continuous improvement and collaboration.
Lead MRB activities, periodic quality reviews, and provide actionable insights.
Lead real-time manufacturing line investigations, identify root causes of issues, and ensure the implementation of corrective actions through comprehensive reporting and follow-up.
Implement and monitor production and process controls, including Process Validation (PV), Equipment Qualification (EQ), Control Plans, and pFMEA.
Maintain compliance with ISO 13485, FDA regulations, and other relevant standards.
Prepare for and support external audits (regulatory, customer) and perform internal pre-audits.
Act as a liaison between R&D and Operations to ensure a smooth transition during NPI and change management And work closely with Production, Supply Chain, and Manufacturing Engineering to improve overall quality performance.