Quality Engineer

Alcon


Tanggal: 3 minggu yang lalu
Kota: Batam, Riau
Jenis kontrak: Penuh waktu
At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers. Are you ready to join us?

This role is part of Alcon's Engineering function, a team focused on improving quality, processes, products, packaging and materials across our business to help deliver brilliant outcomes.The Associate II, Quality Assurance Engineering (Science/Tech/Engineering Path), is primarily responsible for developing and maintaining quality evaluation and control systems, conducting inspections and tests, and performing root cause analysis to ensure reliability standards. You will apply advanced technical knowledge and problem-solving skills.

Specifics Include:

  • 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 Can You Bring to Alcon:

  • 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

Why Join Us:

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

ATTENTION: Current Alcon Employee/Contingent Worker

If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.

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