Assistant Manager – Quality Management (QMS)

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

Job summary

A leading healthcare firm in Penang is seeking an Assistant Manager for Quality Management (QMS). This role involves applying engineering principles to ensure quality standards, leading ISO compliance efforts, and managing quality assurance initiatives. Candidates should have a Bachelor's degree in sciences or engineering and at least 5 years of relevant experience in quality management systems. Strong problem-solving and risk management skills are essential.

Qualifications

• 5 years of experience in quality management or a related field.
• Understanding of ISO standards, specifically ISO 13485:2016 and QSR Part 820 CFR.

Responsibilities

• Apply engineering principles to meet quality and cost standards.
• Analyze product specs to recommend process improvements.
• Lead ISO project implementation and manage certification processes.

Skills

Problem solving methodology

Change control management

Risk management

Education

Bachelor’s degree in sciences or engineering

Job description

Assistant Manager – Quality Management (QMS)

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.

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.

Requirements

Bachelor’s degree in any field preferable in sciences and engineering.

5 years experiences 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.