Assistant Manager Quality Management (QMS)

B. Braun Melsungen AG; Bayan Lepas; On-site; MYR 70,000 - 90,000; Full time

Job summary

A leading global medical technology company in Penang seeks an Assistant Manager for Quality Management (QMS). This role involves overseeing quality standards, driving process improvements, and ensuring ISO compliance. The ideal candidate will possess a Bachelor’s degree and 5 years of relevant experience, particularly with ISO 13485. This position offers career development opportunities within a company committed to improving global health.

Benefits

Retirement benefit scheme

Long service award

Medical insurance

Training and development programs

Education assistance program

Qualifications

• Requires 5 years of experience in quality management.
• Understanding of ISO 13485:2016 and QSR Part 820 CFR is essential.
• Must excel in problem-solving methodologies and risk management.

Responsibilities

• Define fabrication and assembly steps to meet quality standards.
• Analyze product specs to recommend process improvements.
• Lead ISO project implementation and manage certification processes.

Skills

ISO 13485 knowledge

Problem solving

Change control management

Risk management

Education

Bachelor’s degree in sciences or engineering

Job description

Assistant Manager – Quality Management (QMS)

You're an important part of our future. At B. Braun, we protect and improve the health of people worldwide. You support this vision, bringing expertise and sharing innovation, efficiency and sustainability as values. That’s why we would like to keep developing our company with you.

Are you passionate about the role of Assistant Manager – Quality Management (QMS) and have experience in ISO 13485? If so, this opportunity could be for you! Join us at B. Braun, a leader in the medical devices industry, where your skills and experience will be recognized and celebrated. Take the next step in your career with us and help shape the future of healthcare!

Responsibilities

Process & Product Improvement

• Apply engineering principles to define fabrication and assembly steps that meet quality and cost standards.
• Analyze product specs and drawings to recommend process improvements that reduce risk and enhance consistency.
• Participate in continuous improvement initiatives (Kaizen, Lean) and support quality enhancement efforts.

Quality Control & Data Analysis

• Coordinate Verification Matrix activities with relevant CoEs.
• Collect, analyze, and summarize data to identify root causes of manufacturing anomalies.
• Initiate NCIR/CAPA requests for holdbacks and customer complaints per SOP and criteria.

Statistical & Measurement Systems

• Coordinate QS-Stat training and SOP updates.
• Support harmonization of inline tests, IPQC, and FC for effective, cost-optimized inspections.
• Oversee MSA activities for test, inspection, and measurement equipment.

Test Method & SPC Implementation

• Train and coordinate test method verification/validation activities.
• Contribute to plant projects such as SPC implementation relevant to area of responsibility.

Communication & Collaboration

• Clearly communicate technical issues across teams with diverse technological backgrounds.
• Collaborate with cross-functional teams to ensure alignment on quality and process standards.

ISO Compliance & Training

• Ensure compliance with ISO standards and manage certification processes.
• Lead ISO project implementation and train key personnel on ISO principles.
• Design and maintain continuous improvement and audit processes for sustained compliance.

Qualifications

• Bachelor’s degree in any field preferable in sciences and engineering.
• 5 years of experience working in quality management related field and experiences working in quality management system.
• Have a good understanding about ISO standard such as ISO 13485:2016, QSR Part 820 CFR.
• Good in problem solving methodology, change control management and risk management.

About B. Braun

Founded in Germany in 1839, B. Braun is a leading medical technology company with over 66,000 employees in 64 countries. Specializing in infusion therapy, orthopaedics, neurosurgery, anaesthesia, and more, B. Braun develops high-quality products and services that improve global health. In Asia Pacific, B. Braun employs over 16,000 people across 10 production sites and 16 business offices.

Established in 1972, B. Braun Medical Industries in Penang is the regional headquarters for APAC. With more than 7,000 employees, the plant located in Penang is among the largest manufacturers of medical, surgical and pharmaceutical products not only in Malaysia but also in the APAC region. It also houses the Centre of Excellence for Intravenous Access.

Benefits

• Retirement benefit scheme
• Long service award
• Medical insurance
• Training and development programs
• Education assistance program

Next Steps

Once you click on the link to Apply, you will be directed to update your personal information and submit your CV. Our Talent Acquisition team will carefully review your application, and if you pass the CV screening you will be invited for an interview. If you stand out and meet our requirements, we will present you with an offer and guide you through our seamless onboarding process. Join us and be part of something extraordinary!

We appreciate different perspectives, thoughts, experiences and backgrounds. By strengthening an appreciative, inclusive, respectful and equal working environment, we create a culture in which all our employees feel free to be who they are.

To find out more about our commitment to diversity clickhere