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.
Requirements: Bachelor's degree in engineering, production technology, science, quality assurance, mechanical engineering, or other related field.
A minimum of 3 years of experience as a quality manager or in a similar role.
A minimum of 5 years of experience as a product quality engineer
In-depth knowledge of quality assurance methodologies, standards, and regulatory requirements (e.g., ISO 13485, FDA, MDR).
Fluent in English, both written and verbal.
Advantages:
Experience working in medical device, pharmaceutical
Proficiency in statistical analysis tools (e.g., Minitab, JMP) and methods such as Six Sigma.
Expertise in quality systems, CAPA management, and risk assessment.
Familiarity with SAP or other ERP systems for quality tracking.
Experience in NPI (New Product Introduction) and production readiness activities.
Knowledge of advanced manufacturing processes, automation, and Industry 4.0 principles.
This position is open to all candidates.