Deskripsi pekerjaan
Esco Lifesciences Group berkantor pusat di Singapura dan telah berekspansi secara global dengan fasilitas di 43 lokasi, menyediakan ekosistem alat ilmu hayati, diagnostik, dan teknologi kesehatan. Perusahaan menawarkan lingkungan kerja multinasional yang dinamis dan berorientasi pada inovasi masa depan. Sebagai Product Quality Engineer yang bertempat di Bintan, Anda akan bertindak sebagai pengawas kualitas untuk kelompok produk tertentu mulai tahap NPI hingga pemeliharaan. Tanggung jawab meliputi pengelolaan dokumentasi DHF/DMR, pelaksanaan validasi dan verifikasi produk (V&V), investigasi keluhan pelanggan menggunakan metodologi 8D, penanganan isu non-konformitas, serta memastikan kepatuhan penuh terhadap Sistem Manajemen Mutu seperti ISO 9001 dan ISO 13485.
Tanggung jawab: Act as quality steward for assigned product families from NPI to sustaining stage; Manage DHF/DMR documentation and ensure compliance with regulatory and product standards; Participate in product validation & verification (V&V) activities and quality reviews; Maintain Product Quality Plans, SOPs, work instructions, and inspection standards; Lead/support customer complaint investigations and corrective actions using 8D methodology; Monitor field performance data and drive customer quality improvement initiatives; Support production quality improvement activities, including Kaizen and FPY improvement; Collaborate with SQE to monitor supplier quality and improvement effectiveness; Evaluate quality impact of engineering changes (CCR/CCI) and support sustaining improvements; Handle non-conformance issues and support root cause analysis activities; Ensure compliance with ISO, MDR, and other applicable Quality Management Systems (QMS); Support audits, maintain audit readiness, and present quality performance dashboards and analysis to management; Key Requirements:.
Kualifikasi: Bachelor’s degree in Engineering, mainly in Electrical and Electronics; Minimum 5 years of experience in Quality Engineering or Manufacturing Engineering; Strong knowledge of product quality, reliability, and root cause analysis methods (5 Why, Ishikawa, Fault Tree Analysis); Familiar with ISO 9001, ISO 13485, ISO 14971, and related Quality Management Systems; Understanding of electronics boards, sensors, PCBA quality, and mechanical assemblies; Knowledge of CAPA, 8D methodology, control plans, and non-conformance handling; Strong problem-solving, analytical, and troubleshooting skills; Ability to read and interpret engineering drawings, schematics, and BOMs; Experience in supplier quality evaluation and material quality assessment; Strong communication and cross-functional collaboration skills with technical and non-technical teams; Disciplined in documentation and capable of leading quality investigations and improvement activities; Preferred certifications: CQE, Six Sigma Green Belt (or above), and ISO 9001/ISO 13485 Internal Auditor certification.
Tanggung jawab
- Act as quality steward for assigned product families from NPI to sustaining stage
- Manage DHF/DMR documentation and ensure compliance with regulatory and product standards
- Participate in product validation & verification (V&V) activities and quality reviews
- Maintain Product Quality Plans, SOPs, work instructions, and inspection standards
- Lead/support customer complaint investigations and corrective actions using 8D methodology
- Monitor field performance data and drive customer quality improvement initiatives
- Support production quality improvement activities, including Kaizen and FPY improvement
- Collaborate with SQE to monitor supplier quality and improvement effectiveness
- Evaluate quality impact of engineering changes (CCR/CCI) and support sustaining improvements
- Handle non-conformance issues and support root cause analysis activities
- Ensure compliance with ISO, MDR, and other applicable Quality Management Systems (QMS)
- Support audits, maintain audit readiness, and present quality performance dashboards and analysis to management
- Key Requirements:
Kualifikasi
- Bachelor’s degree in Engineering, mainly in Electrical and Electronics
- Minimum 5 years of experience in Quality Engineering or Manufacturing Engineering
- Strong knowledge of product quality, reliability, and root cause analysis methods (5 Why, Ishikawa, Fault Tree Analysis)
- Familiar with ISO 9001, ISO 13485, ISO 14971, and related Quality Management Systems
- Understanding of electronics boards, sensors, PCBA quality, and mechanical assemblies
- Knowledge of CAPA, 8D methodology, control plans, and non-conformance handling
- Strong problem-solving, analytical, and troubleshooting skills
- Ability to read and interpret engineering drawings, schematics, and BOMs
- Experience in supplier quality evaluation and material quality assessment
- Strong communication and cross-functional collaboration skills with technical and non-technical teams
- Disciplined in documentation and capable of leading quality investigations and improvement activities
- Preferred certifications: CQE, Six Sigma Green Belt (or above), and ISO 9001/ISO 13485 Internal Auditor certification
Informasi lowongan
- Tipe pekerjaan
- Full-time
- Pendidikan
- S1
- Gaji
- Negosiasi