Assistant Quality Manager / Quality Lead (Medical Devices / ISO 13485:2016) - Career Growth Potentia

• Well Established Company
• Basic $6500 - $8000 + AWS + Variable Bonus
• Excellent Welfare and Benefits + Career progression
• Working location: Boon Lay
• Working day: Monday to Friday
• Working hours: 8.30am to 5.30pm
• QMS | ISO 13485:2016 | ISO 14971:2019 | Cleanroom

Job Responsibilities:

• Maintain the Quality Management System to ensure compliance with ISO 13485:2016 requirements, applicable international standard/regulation requirements, and customer requirements
• 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