Quality Engineer

Alcon


Tanggal: 15 jam yang lalu
Kota: Batam, Riau
Jenis kontrak: Penuh waktu
  • 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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