Senior QA/QC Manager - Medical Devices (MDR/FDA)

JAC Recruitment; Kuala Lumpur; On-site; MYR 100,000 - 130,000; Full time

Job summary

A leading medical device manufacturer is seeking a candidate with a degree in engineering and 7-10 years of experience in the Medical Manufacturing industry. The role focuses on continuously improving the Quality Management System (QMS) while managing quality control tasks including inspections and audits. Strong attention to detail, project management experience, and knowledge of product certification for MDR and FDA are essential. Join their mission to deliver innovative medical solutions.

Qualifications

• Minimum Degree in Engineering or a relevant field.
• Minimum 7-10 years working in the Medical Manufacturing industry.
• Experience in project management and leading a team towards project success.
• Experience handling product certification for MDR and FDA.
• Meticulous with strong attention to detail, knowledgeable in QA, QC, and QMS.

Responsibilities

• Continuously improve QMS while ensuring ISO and other regulations are met.
• Manage QC scope covering Final & Incoming Inspection and Packing.
• Plan yearly Internal Audit, ISO audits, and Management Review.
• Monitor and handle customer complaints accordingly.
• Address and report issues related to Suppliers.
• Promote awareness of environmental control activities.
• Ensure QAQC personnel are properly trained.

Job description

A leading medical device manufacturer is seeking a candidate with a degree in engineering and 7-10 years of experience in the Medical Manufacturing industry. The role focuses on continuously improving the Quality Management System (QMS) while managing quality control tasks including inspections and audits. Strong attention to detail, project management experience, and knowledge of product certification for MDR and FDA are essential. Join their mission to deliver innovative medical solutions.