We are desiring to recruit an energetic Quality Manager (Assistant Manager) (ISO13485 | QMS | Medical Devices | West) to join our high-achieving team at EA RECRUITMENT PTE LTD in Boon Lay, West Region.
Growing your career as a Full time Quality Manager (Assistant Manager) (ISO13485 | QMS | Medical Devices | West) is a great opportunity to develop productive skills.
If you are strong in attention to detail, decision-making and have the right attitude for the job, then apply for the position of Quality Manager (Assistant Manager) (ISO13485 | QMS | Medical Devices | West) at EA RECRUITMENT PTE LTD today!
- Medical Device (Well Established Company)
- Basic $6500 - $8000 + AWS + Variable Bonus
- Excellent Welfare and Benefits + Career progression
- Working location: Boon Lay
- Monday to Friday (8.30am to 5.30pm)
- QMS | ISO 13485:2016
- Maintain & Improve QMS
- Handle customer Audits
Job Responsibilities:
- Maintain the Quality Management System to ensure compliance with ISO 13485:2016 requirements, applicable international standard/regulation requirements, and customer requirements
- Managing customers' audits, complaints, and implementing corrective/preventive actions to uphold customer satisfaction and regulatory compliance.
- Identify the gap in the QMS and make continuous improvements to ensure the effectiveness of QMS implementation and consistency with product and process requirements. Lead the training on procedures and practices to QMS requirements
- Lead the internal audit and customer audit, follow-up on audit non-conformance activities till closure
- Responsible for major customer projects and quality deliveries, handling product quality issues, and responding to major customer complaints and quality improvement
- Authorize the release of major customer products
- Manage and verify CAPA, NCR, SCAR handling, root cause analysis, and action taken
- Risk management, validation and verification activities
- Provide the necessary training, such as QMS, supplier management, design control, MSA, G R&G, 8D etc.
- Support on monthly quality objective and KPI review
- Support on Quality Management Review
- Any other duties as assigned from time to time
Job Requirements:
- Bachelor’s Degree with minimum 5 years of experience in quality management/ assurance and/or risk assessment in medical device industry
- Qualified lead auditor or ISO 13485:2016 internal auditor, be familiar with ISO 14971:2019, Cleanroom, and applicable regulatory and standards
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.
LIONG ZHAO GUAN (R22107632)
EA Recruitment Pte Ltd
EA License No: 21C0492
Benefits of working as a Quality Manager (Assistant Manager) (ISO13485 | QMS | Medical Devices | West) in Boon Lay, West Region:
● Excellent Benefits Package
● Company offers career progression opportunities
● Leading Industry Pay