Senior Quality Engineer

Description

• Provide end-to-end partnering to provide quality oversight to ensure alignment with stakeholders, customers and patient expectations
• Manage quality system platforms (Out of specifications (OOS), deviations, change control, Corrective and Preventive Actions (CAPA) and/or Document Control)
• Lead / participate in safety & quality enhancement initiative to drive continuous improvements within and across departments
• Promote quality culture and culture of continuous improvement
  

• Ensure that all products and processes adhere to both internal and external quality standards, including regulatory requirements
• Lead and contribute to safety and quality improvement initiatives aligned with plant KPI and objectives
• Lead QA department meetings to drive on-time tasks deliverables
• Manage quality platforms (Out of specifications (OOS), deviations, change control, Corrective and Preventive Actions (CAPA) and/or Document Control) ensuring alignment with plant KPI and objectives

• Provide end-to-end partnering to provide quality oversight, collaborating with assigned departments to address internal non-conformance promptly while meeting delivery targets
• Oversight of OOS, deviations, change control and validations to ensure compliance and timely closure
• Provide guidance to batch tracing and batch disposition
• Participate in A3s, providing quality guidance to root cause analysis, effective CAPAs
• Provide training on GMP-related topics
• Involve in CAPA management, compliance and timely closure
• On time review and approval of documentation and procedures
• Monitor, assess and improve quality programs to support operational excellence and compliance
• Compile and analyze monthly quality metrics, highlighting trends and areas for improvement
• Provide guidance and training to QA Engineers & Junior QA Engineers and/or other team members on quality-related processes and practices
• Lead and participate in internal and shop floor audits, ensuring compliance with quality standards
• Support and contribute to Lean Sigma program and activities towards delivery of the set target
• Assist the QA Manager in ensuring compliance with the ISO 15378 / 9001 requirements
• Maintain accurate and comprehensive quality records and reports to support compliance, audits and continuous improvement processes
• Other duties as assigned by the superior

Qualifications

Highest qualification: University

• Bachelor's Degree In Engineering or Science required
• Proficient in computer applications, particularly Microsoft Office
• Preferably 5-8 years' work experience in QA related activities
• Familiarity with SAP, cGMP, Lean principles, Power BI and/or ISO standards is advantageous
• Preferably with exposure to medical device, pharmaceutical or related manufacturing environment