Quality Engineer – Manufacturing & Digital Assurance

Medifox DAN GmbH; Johor Bahru; On-site; MYR 72,000 - 110,000; Full time

Job summary

Medifox DAN GmbH seeks a Quality Engineer to support manufacturing with quality objectives, risk-based planning and robust validation activities. You will contribute to continuous improvement of quality systems and ensure compliance with QMS and regulatory standards.

Responsibilities include supporting digital quality initiatives, problem solving, and collaboration across manufacturing, engineering and quality teams to deliver reliable product quality in a regulated environment.

Qualifications

• Bachelor's degree in Engineering or Science with at least 3 years' experience in a regulated volume manufacturing industry.
• Experience with Quality Systems, Manufacturing Quality, risk management, process validation and structured root cause/problem-solving methodologies.
• Ability to apply established Quality Engineering methods to support manufacturing quality delivery, investigations, validation, digital assurance/CSV/CSA deliverables.
• Independent and proactive learner, able to work under guidance of senior team members while building capability in digital quality, automation, advanced manufacturing, digital assurance and Quality by Design.
• Ability to use quality data and manufacturing information to identify trends, support decisions and recommend improvements.
• Good planning and organisational skills, with the ability to take initiative and ownership of assigned deliverables.
• Strong communication and collaboration skills, with the ability to build positive working relationships with manufacturing, engineering and quality partners.

Responsibilities

• Support quality objectives by applying Quality Engineering methods in manufacturing.
• Participate in new product/process introductions with QBD and risk-based planning.
• Support readiness activities including validation deliverables and control strategy.
• Apply QA standards to drive consistency and standardization across manufacturing teams.
• Use quality data to identify trends and support investigations.
• Contribute to continuous improvement of quality systems and practices.
• Provide quality guidance through training and coaching.
• Partner with functions to ensure Quality requirements early in changes.
• Support digital quality pilots and engage CSV/CSA experts.
• Foster a quality culture across manufacturing and partners.
• Ensure compliance to QMS and regulatory standards.
• Perform internal/external audits as required.

Skills

Quality Systems

Manufacturing Quality

Risk Management

Process Validation

Root Cause Analysis

Quality by Design

Digital Quality

Automation

Digital Assurance

Quality Planning

Data-driven decision making

Communication & Collaboration

Education

Bachelor’s degree in Engineering or Science

Tools

AI tools

MES

CSV/CSA

Job description

Medifox DAN GmbH seeks a Quality Engineer to support manufacturing with quality objectives, risk-based planning and robust validation activities. You will contribute to continuous improvement of quality systems and ensure compliance with QMS and regulatory standards.

Responsibilities include supporting digital quality initiatives, problem solving, and collaboration across manufacturing, engineering and quality teams to deliver reliable product quality in a regulated environment.