Snr Quality/System Engineer (Station: Batam)

at  Yeakin Plastic Industry Pte Ltd

Singapore, Southeast, Singapore -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate24 Oct, 2024USD 5000 Monthly25 Jul, 2024N/ARegulatory Requirements,ManufacturingNoNo
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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