Job Description

• Plastic | Polymer (Medical | Injection Molding)
• Basic $6000 to $7000 + AWS
• Excellent Welfare and Benefits + Career progression
• Working location: West
• Working hours: Normal Working Hours
• ISO 9001, ISO 13485 and/or US FDA GMP QMS
• cGMP, ISO 13485 and FDA QSR 21 CFR 820 | MDSAP

Job Responsibilities:

• To develop, implement and maintain site QMS policies and procedures in accordance with ISO and customers’ requirements
• To support the site Quality Management Representative or designee to ensure a compliant and efficient QMS
• To drive quality culture by conducting regular trainings, internal audits and review of key QMS metrics
• To work closely with local and regional stakeholders to ensure the overall effectiveness and compliance of QMS to support business strategies
• To lead / support regional QMS activities such as SF-LMS, SAP-DMS and quality audits
• Provide support in root cause investigation and failure analysis on the customer / field complaints and production issues, especially on the assembly and automation process related quality issues
• Provide support on product / process qualifications by ensuring quality requirements are fulfilled
• Review non-conformance materials / components and work orders in a timely manner and make recommendations for their disposition to support the sales fulfilment process to ensure predictable product flow
• Maintain a safe and healthy work environment by complying with all related safety regulations in the company
• Ensure existing or potential hazard areas are identified and corrected to prevent injury to employees or damage to property
• Other duties as assigned by superior

Requirements:

• Bachelors’ Degree in STEM or equivalent
• Experience in Quality Systems / Quality Engineering capacity in a commercial or manufacturing environment
• 3 years QMS Auditor / Lead Auditor experience

Candidates are encouraged to apply this position via Apply Now button with the following information in the resume

• Work experiences and job responsibilities

• Current and Expected salary

• Reason for leaving

• Date of availability

• Education background
  

We regret that only shortlisted candidates will be contacted.


NG DIAUM YEE (R2198031) EA Recruitment Pte Ltd EA License No: 21C0492