Quality Engineer
Alcon · Batam, Indonesia
Sekilas tentang pekerjaan ini
Sebagai Quality Engineer di Alcon, Anda akan mendukung investigasi mutu, validasi, kepatuhan, dan perbaikan proses di Batam, Indonesia. Posisi ini ditujukan bagi kandidat dengan gelar sarjana terkait; pengalaman kerja relevan 1–2 tahun diutamakan.
Tugas utama
- Menangani investigasi Non-Conformance, RCA, serta pembuatan dan pelaksanaan CAPA.
- Meninjau dan menjalankan studi engineering, validasi, serta kualifikasi.
- Melakukan penilaian risiko produk, proses, dan sistem.
- Mengawasi mutu dan sistem terkomputerisasi di area operasional.
- Mendukung perubahan dan perbaikan proses bersama tim manufacturing.
Kualifikasi utama
- Gelar sarjana di bidang Engineering atau bidang terkait sains.
- Pengalaman kerja relevan 1–2 tahun diutamakan.
- Pengalaman menangani investigasi Non-Conformance, Root Cause Analysis (RCA), dan CAPA.
- Pengalaman mendukung validasi dan kualifikasi produk, proses, bahan baku, atau sistem terkomputerisasi.
- Kemampuan komunikasi dan pengelolaan stakeholder yang kuat; komunikasi lisan dan tulisan bahasa Inggris yang baik.
Ringkasan ini dibuat dengan AI dari deskripsi di bawah. Yang berlaku adalah deskripsi lengkapnya di situs Alcon.
Deskripsi pekerjaan
- 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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