QAQC Manager

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

Our client is a Japanese medical device manufacturing company specializing in the cardiovascular, neurovascular, and gastrointestinal fields. Be a part of their growing team and join their mission to provide cutting-edge technology that not only facilitates a minimally invasive treatment for patients but also addresses the everyday challenges faced in medical practice.

Job Responsibilities

• Continuously improve QMS while ensuring ISO, customer requirements, and other regulations are met by conducting analysis and implementing CAPA.
• Manage QC scope covering Final & Incoming Inspection, Return Product, and Packing.
• Plan yearly Internal Audit, ISO audits, and Management Review.
• Ensure complaints from Customers are monitored and handled accordingly.
• Ensure issues related to Suppliers are addressed and reported accordingly.
• Promote awareness of environmental control activities and the impact on product cleanliness.
• Ensure QAQC personnel are properly trained and possess the required skills and qualifications.

Job Requirements

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