Quality Engineer

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

• 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.

At Alcon, we are committed to helping people see better. We believe patients should have access to quality eye care regardless of their economic circumstances; however, barriers to good eye health exist for patients in both developed and emerging markets. Alcon develops and manufactures innovative devices to serve the full life cycle of eye care needs. Its surgical group is one of the largest makers of equipment used for cataract removal and laser vision correction. Its consumer products include the well-known Opti-Free line of contact lens solutions and related products. Alcon, which was founded in 1945, sells its products in 180 countries worldwide.