QA Engineer - Manufacturing (Fixed Term)

Medifox DAN GmbH; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

Medifox DAN GmbH is seeking a Quality Engineer to strengthen our manufacturing quality program in a regulated environment. You will apply Quality by Design, risk-based planning, and robust problem solving to ensure product quality and process reliability.

The role involves collaboration across manufacturing, engineering and quality partners, with focus on continuous improvement, data-driven decisions and adherence to the company’s QMS.

Qualifications

• Bachelor's degree in Engineering or Science; regulated manufacturing experience preferred.
• Experience with Quality Systems, manufacturing quality, risk management and process validation.
• Ability to apply Quality Engineering methods to support manufacturing quality, investigations and validation deliverables.
• Independent and proactive learner; able to work under guidance while building digital quality capabilities.
• Ability to use quality data to identify trends, support decisions and drive improvements.
• Strong planning, organisational and initiative-taking skills.
• Excellent communication and collaboration with manufacturing, engineering and quality partners.

Responsibilities

• Support Quality Engineering to achieve quality, availability and value objectives.
• Contribute to new product/process introductions with Quality by Design and risk-based planning.
• Support readiness activities including quality planning, risk assessments and validation deliverables.
• Apply QA standards and tools to promote consistency and standardisation across manufacturing teams.
• Use data and audit findings to identify trends and drive preventive actions.
• Contribute to continuous improvement of quality systems and engineering practices.
• Provide quality guidance through training and coaching on problem solving and data-driven decisions.
• Partner with functions to consider quality early in process, equipment and automation changes.
• Participate in digital quality initiatives and advise on CSA/CSV-related efforts.

Skills

Quality data analysis

Root cause analysis

Structured problem solving

Communication

Planning & organization

Collaboration

Independent learner

Education

Bachelor's degree in Engineering or Science

Tools

Quality by Design

CSV/CSA

MES

Job description

Let's talk about Responsibilities

• Support Manufacturing to achieve Quality, Availability and Value objectives by applying established Quality Engineering methods and contributing to reliable manufacturing quality performance.
• Participate in and support new product, process, technology and manufacturing capability introduction, applying Quality by Design, risk-based quality planning and appropriate quality controls through XFT deliverables and phase transitions.
• Support manufacturing readiness activities, including quality planning, risk assessments, validation activities, digital assurance/CSV/CSA deliverables where applicable, control strategy execution and launch/post-launch learning.
• Apply established Manufacturing QA standards, methods, playbooks and tools to support consistency, standardisation and adoption of proven approaches across manufacturing teams.
• Use quality and manufacturing data, including NCP/CAPA learning, validation outputs, audit findings and process performance signals, to identify trends, support investigations, recommend preventive actions and contribute learning to future Quality Engineering solutions.
• Contribute to continuous improvement of manufacturing quality systems, processes and engineering practices, supporting improved Right First Time performance and reduction of repeat or systemic quality issues.
• Provide quality / technical guidance through training, consultation and coaching, building capability in structured problem solving, risk management, process validation, digital assurance awareness and data-driven decision making.
• Partner with Manufacturing Engineering, Operations and other functions to ensure Quality requirements are considered early in process, equipment, technology, automation, MES and digital manufacturing changes.
• Participate in digital quality, automation, advanced manufacturing or transformation pilots where required, supporting development, testing and operational adoption of new quality capabilities and engaging specialist CSV/CSA expertise where applicable.
• Foster a quality culture through education, consultation and day-to-day engagement with manufacturing and cross-functional partners.
• Ensure risks of non-compliance and related business risks are identified, assessed and mitigated with support from senior team members where required.
• Ensure compliance to the ResMed QMS and applicable regulatory standards.
• Perform or support internal, external and supplier audits as required.

Let's talk about Qualifications and Experience

Required

• Bachelor's degree in Engineering or Science with at least 3 years' experience in a regulated volume manufacturing industry.
• Experience or exposure in 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 where applicable, quality planning and improvement activities.
• 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.

Preferred

• Experience in Quality and/or Regulatory positions in the medical device industry.
• Experience in Quality Systems, Manufacturing Quality, process validation and risk management methodologies.
• Demonstrated capability in using AI tools or data-driven technologies for efficiency improvement, quality insights and decision support.
• Exposure to MES/digital quality, CSV/Computer Software Assurance (CSA), automation, advanced analytics, Quality by Design or advanced quality planning.
• Exposure to manufacturing readiness, new product introduction, process technology changes, equipment changes, validation activities or software-enabled manufacturing systems in a regulated environment.
• Interest in developing toward senior technical Quality Engineering contribution across manufacturing quality, automation, digital quality, risk-based digital assurance and proactive assurance.

Joining us is more than saying "yes" to making the world a healthier place. It's discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates.