Snr Quality/System Engineer (Station: Batam)
at Yeakin Plastic Industry Pte Ltd
Singapore, Southeast, Singapore -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 24 Oct, 2024 | USD 5000 Monthly | 25 Jul, 2024 | N/A | Regulatory Requirements,Manufacturing | No | No |
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Description:
REQUIREMENTS
- Min. Degree in Quality Assurance, Manufacturing or equivalent.
- Min. 3 years of experience in Quality Management Systems in the plastic injection moulding or medical device industry for IATF16949, ISO9001, ISO14001 and ISO13485.
- Knowledge of regulatory requirements and standards relevant to manufacturing such as ISO45001/OHSAS18001 and ISO14001
- Strong customer focus with complaint investigation, significant event reporting and CAPA skills.
- Internal Auditor certification.
- Strong data analysis skills and proficiency in electronic data management systems.
- Good understanding of quality management systems and tools such as PPAP, FMEA, and SPC.
- Ability to work independently and collaborate effectively with cross-functional teams.
- Location: Batam, Indonesia.
Responsibilities:
- Act as the Quality Management Representative of the company.
- Ensure effectiveness and compliance to ISO/IATF/QMS and various regulatory requirements as needed.
- Lead site quality team to drive operation and product quality improvements via data driven metrics.
- Oversee and support supplier quality, SCAR, product inspection, equipment calibration, CAPA, complaint investigation, change control, LMS training, and NPI activities.
- Chair quality management reviews and manage Internal & External audits.
- Support global quality system process integration, harmonization, and simplification. Managing local implementation and changes.
- Escalate and manage any significant events such as safety, product shipping holds due to quality, regulatory, or any compliance issue.
- Lead or support identified special projects and key initiatives as needed.
- Work cross-functionally to achieve Batam/Singapore site objectives.
REQUIREMENT SUMMARY
Min:N/AMax:5.0 year(s)
Pharmaceuticals
Production / Maintenance / Quality
Clinical Pharmacy
Graduate
Proficient
1
Singapore, Singapore