Quality Engineer

Location: Batam, Indonesia

Remote Type: Not applicable

Time Type: Full time

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.

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