Quality Engineer – QA & Validation

About the role

Alcon is seeking a Quality Engineer to join its Engineering function in Indonesia. The role focuses on developing and maintaining quality evaluation systems, ensuring compliance with regulatory standards, and driving continuous improvement across products, processes, and equipment.

Key responsibilities

• 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, statistical analysis, and risk‑based validation to ensure process control.
• 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.
• Execute and approve computerized system validation (CSV) and qualification activities.
• Collaborate with cross‑functional teams on CSV, data integrity, and digitalization initiatives.
• Develop and improve SOPs, guidelines, and validation processes.
• Provide quality oversight for computerized systems and deliver CSV/DI training.
• Partner with manufacturing teams to drive process improvements and ensure HSE adherence.

Required profile

• Bachelor’s degree in Engineering or Science (Electrical Engineering preferred).
• Hands‑on experience with PLC, HMI, and SCADA systems.
• Strong understanding of quality systems and regulatory compliance.
• Good command of spoken and written English.
• 1–2 years of relevant experience or recent graduate with strong technical knowledge in automation.
• Experience with packaging machines is a plus.

Required skills

• PLC
• HMI
• SCADA
• FDA 21 CFR Part 11
• EU Annex 11
• Computerized System Validation (CSV)
• Risk‑based validation
• Statistical analysis
• Root cause analysis
• CAPA management
• SOP development
• Data integrity

What we offer

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