Quality Engineer

Alcon Research


Job Location:

Batam - Indonesia

Monthly Salary: Not Disclosed
Posted on: 7 days ago
Vacancies: 1 Vacancy

Job Summary

At Alcon were passionate about enhancing sight and helping people see brilliantly. With more than 25000 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 Alcons Engineering function a team focused on improving quality processes products packaging and materials across our business to help deliver brilliant 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:

  • Bachelors 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)
  • 12 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.

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Required Experience:

IC

At Alcon were passionate about enhancing sight and helping people see brilliantly. With more than 25000 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 yo...

About Company

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Our mission is to provide innovative vision products that enhance quality of life by helping people see better. From vision research to eye health, learn more at Alcon.com.

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