Quality Engineer: CAPA, Validation & Compliance

Alcon MX; Batam; On-site; IDR 180,000,000 - 280,000,000; Full time

Job summary

Alcon MX seeks a Quality Assurance professional to assist, review, and lead non-conformance investigations, RCA, and CAPA. The role covers validation/qualification of products, processes, raw materials, and computerized systems, plus risk assessments and change controls.

You will collaborate with QA, Manufacturing, MST & Engineering and ensure lifecycle compliance for computerized systems. Strong English communication and stakeholder management are essential; prior experience in GxP and HSE

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.
• Proficient in English (verbal and written).

Responsibilities

• Assist/Execute/Lead Non-Conformance Investigation, RCA, and 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.
• 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 from other Alcon sites.

Skills

Non-Conformance investigations

Root Cause Analysis (RCA)

CAPA

Validation & qualification activities

Stakeholder management

English communication

Education

Bachelor's degree in Engineering or Science

Tools

Computerized systems software (GxP)

Job description

Alcon MX seeks a Quality Assurance professional to assist, review, and lead non-conformance investigations, RCA, and CAPA. The role covers validation/qualification of products, processes, raw materials, and computerized systems, plus risk assessments and change controls.

You will collaborate with QA, Manufacturing, MST & Engineering and ensure lifecycle compliance for computerized systems. Strong English communication and stakeholder management are essential; prior experience in GxP and HSE