Title:  Senior Quality Engineer

Job Summary

In this role, you will

• 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

Essential Duties and Responsibilities

• 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

Education

• Bachelor's Degree In Engineering or Science required

Work Experience

• 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

Preferred Knowledge, Skills and Abilities

• Comprehensive understanding of relevant standard operating procedures in accordance with company policy related to the position covered by this Job Description
• Contribute to Lean Sigma initiatives and activities aimed at achieving set targets, minimize waste, and promoting efficient work execution
• Adherent to the company’s safety policy consistently
  • Ensure use of Personal Protective Equipment (PPE) in respective work environments for all members
  • Report unsafe conditions or acts to responsible personnel for corrections and improvements.
• Always commit to the company’s quality policy
  • Ensure gowning procedures are followed at work environments for all members
  • Lead monitoring / improvement activities to enhance operational support activities
  • Participate in establishment and maintenance of documented procedure
• Good knowledge of cGMP requirement and strong quality mindset

Additional Requirements

• Manufacturing environment
• 20/30 Vision minimum, at near and/or far with at least one eye with or without corrective lenses and no color deficiency