Quality Engineer

Alcon; Batam; On-site; IDR 120,000,000 - 168,000,000; Full time

Job summary

Alcon is seeking a quality Assurance Professional in Batam to assist and lead non-conformance investigations, RCA activities, and CAPA execution. The role reviews engineering studies, validations, and qualifications for products, processes, raw materials, and computerized systems, while performing risk assessments and driving improvement projects.

Ideal candidates have a bachelor's degree in engineering or science, 1–2 years of relevant experience, and strong English communication.

Qualifications

• Bachelor's degree in Engineering or a Science-related field.
• 1-2 years of relevant work experience preferred.
• Experience handling Non-Conformance investigations, RCA, and CAPA.
• Experience supporting validation and qualification activities for products, processes, raw materials, and computerized systems.
• Strong communication and stakeholder management skills.
• Good verbal and written communication skills in English.

Responsibilities

• Assist/Execute/Lead Non-Conformance Investigation, RCA and CAPA.
• Review/execute engineering studies, validation and qualification activities for products, processes, raw materials, and computerized systems.
• Perform risk assessment for product/process and system.
• Support/lead Change Requests for product/process improvement.
• Conduct quality oversight at operation areas on a periodic basis.
• Communicate issues related to product quality, disposition of non-conforming products and escalations.
• Support Compliance Improvement Program and liaise with QA/Manufacturing/MST Engineering.
• Ensure lifecycle requirements for Computerized Systems and their data are followed.

Skills

NCR & RCA

CAPA implementation

Risk assessment

Change control

Quality oversight

GxP compliance

Validation support

Qualification

HSE awareness

English communication

Education

Bachelor's degree in Engineering or Science

Tools

Computerized Systems

Validation/Qualification

Job description

• Assist/Execute/Lead Non-Conformance Investigation, RCA, and the generation/execution of CAPA.
• Review/execute engineering studies/validation/qualification activities for new/existing product/process/raw material/computer systems.
• Perform risk assessment for product/process and system.
• Support/lead Change Request for any product/process improvement.
• Conduct quality oversight at the operation area on a periodic basis.
• Communicate issues related to product quality, disposition of non-conforming products & escalations.
• Support and involved in Compliance Improvement Program.
• Work with manufacturing to implement process improvements.
• Perform assessment, determines GxP applicability (Direct/Indirect impact) of the system.
• Conduct quality oversight for the computerized systems at the operation area on a periodic basis.
• Ensure compliance with lifecycle requirement for Computerized System and its data.
• Review/Execute/Approve validation/qualification activities for new/existing computerized systems.
• Ensure compliance and provide guidance plus technical support to QA/Manufacturing/MST& Engineering.
• Work in-accordance with HSE manual and documented procedures, and reporting HSE issues.
• Leveraging good practices by referencing other Alcon sites.
• Review historical quality performance (non-conformance, customer complaint, escalation) from other Alcon sites.

• Assist/Execute/Lead Non-Conformance Investigation, RCA, and the generation/execution of CAPA.
• Review/execute engineering studies/validation/qualification activities for new/existing product/process/raw material/computer systems.
• Perform risk assessment for product/process and system.
• Support/lead Change Request for any product/process improvement.
• Conduct quality oversight at the operation area on a periodic basis.
• Communicate issues related to product quality, disposition of non-conforming products & escalations.
• Support and involved in Compliance Improvement Program.
• Work with manufacturing to implement process improvements.
• Perform assessment, determines GxP applicability (Direct/Indirect impact) of the system.
• Conduct quality oversight for the computerized systems at the operation area on a periodic basis.
• Ensure compliance with lifecycle requirement for Computerized System and its data.
• Review/Execute/Approve validation/qualification activities for new/existing computerized systems.
• Ensure compliance and provide guidance plus technical support to QA/Manufacturing/MST& Engineering.
• Work in-accordance with HSE manual and documented procedures, and reporting HSE issues.
• Leveraging good practices by referencing other Alcon sites.
• Review historical quality performance (non-conformance, customer complaint, escalation) from other Alcon sites.

Qualifications:

• Bachelor's degree in Engineering or a Science-related field.
• 1-2 years of relevant work experience are preferred.
• Experience handling Non-Conformance investigations, Root Cause Analysis (RCA), and Corrective and Preventive Actions (CAPA).
• Experience supporting validation and qualification activities for products, processes, raw materials, and/or computerized systems.
• Strong communication and stakeholder management skills.
• Good verbal and written communication skills in English.