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Associate II, Quality Assurance Engineering (Science/Tech/Engineering Path)

Alcon
Batam, Indonesia
On-site

About this role

Job title: Associate II, Quality Assurance Engineering (Science/Tech/Engineering Path)

About the Role The Associate II, Quality Assurance Engineering in Alcon's Engineering function is responsible for developing and maintaining quality evaluation and control systems, conducting inspections and tests, and performing root cause analyses to ensure reliability and regulatory compliance. You will apply advanced technical knowledge and collaborate with cross-functional teams to drive process improvements and ensure quality across products and packaging.

What You'll Do

  • Develop, implement, and maintain quality evaluation and control systems and protocols
  • Design and improve inspection, testing, and evaluation processes for products and equipment
  • Conduct quality assurance testing and statistical analysis to ensure process control and mitigate risks
  • Perform root cause analysis and lead corrective and preventive actions (CAPA)
  • Review and approve investigations, CAPAs, validations, and verifications
  • Ensure compliance with FDA 21 CFR Part 11 and EU Annex 11 requirements
  • Support or lead non-conformance investigations and corrective actions
  • Execute and approve computerized system validation (CSV) and qualification activities
  • Apply risk-based validation approaches and perform system GAP assessments
  • Collaborate with cross-functional teams on CSV and data integrity (DI) initiatives
  • Develop and improve SOPs, guidelines, and validation processes
  • Support digitalization and global e-compliance initiatives
  • Lead or support change management activities for system/process improvements
  • Provide quality oversight for computerized systems and ensure lifecycle compliance
  • Deliver CSV/DI training and support compliance improvement programs
  • Partner with manufacturing teams to drive process improvements
  • Ensure adherence to HSE (Health, Safety, and Environment) procedures

What We're Looking For

  • Bachelor’s degree in Engineering or Science (Electrical Engineering is preferred)
  • Hands-on experience with PLC, HMI, and SCADA systems
  • Strong understanding of quality systems and compliance requirements
  • Good command of English (spoken and written)
  • 1–2 years of relevant experience is an advantage; open to fresh graduates with strong technical knowledge in automation systems
  • Experience with packaging machines is a plus

Nice to Have

  • Packaging machines experience is a plus

Compensation & Benefits

  • Opportunity to work with a leading global medical device company
  • Collaborative, diverse, and supportive team environment
  • Competitive compensation package and comprehensive benefits
  • Continuous learning and development opportunities

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