Ambu A/S is currently looking for a QAE Engineer to be based in Penang Ambu Global Hub.
Join a dynamic team where your work directly supports medical professionals in solving real-world challenges. This role reports to the QAE Section Manager and offers a unique opportunity to contribute to innovations that improve patient care. If you're passionate about making a difference and thrive in a problem-solving environment, we’d love to hear from you.
In this role, your primary responsibility is to participate in product failure investigations related to market complaints, working as part of a dedicated team of 10 members. As a complaint handler, you’ll have the opportunity to collaborate closely with colleagues from manufacturing sites, as well as teams in R&D, NPI (New Product Introduction), and external suppliers throughout the investigation process. You will also be involved in analyzing top defects from market complaints to support product and process improvements for our medical devices.
Joining our Complaint Investigation Team provides a strong foundation for professional growth in quality, engineering, and cross-functional collaboration. By participating in product failure investigations and analyzing top market defects, you will strengthen your analytical thinking, root cause analysis, and problem-solving skills. Collaborating with teams from manufacturing, R&D, NPI, and suppliers offers exposure to different functions and deepens your understanding of the end-to-end product lifecycle. This role also fosters strategic thinking, enabling you to transform complaints into actionable insights that contribute to device enhancements and ultimately lead to improved product quality for our customers.
Key responsibilities
Your main responsibilities will include:
- Participate in product failure investigation from market feedback of existing/new devices, work with supplier / Ambu’s manufacturing sites / project team / R&D and/or NPI team to replicate the reported failure and identify the cause of the product failure.
- Conduct meeting with supplier and/or counterpart from other Ambu’s sites to assist in complaint investigation – if required.
- Review the response of product failure investigation from supplier and/or counterpart from other Ambu’s sites and conclude / complete the complaint investigation reporting.
- Involve in top 80% defect analysis from market complaint and compile the analysis report.
- Work with QM R&D / QM Operation - to provide input in the update of product / process risk document that initiated due to market complaint.
- Involve in CAPA / NCR / Planned Deviation as required.
- Involve in other Quality Management (QM) function – as identified.
Suggested candidate profile
Skills and experiences can be earned in many different ways, and we understand that the best fit for the role cannot be prescribed on paper. You are however likely to succeed in this position if you:
- A bachelor’s degree in engineering, science, or equivalent.
- Experienced in Quality Assurance (QA) or Quality Control (QC) is considered an advantages.
- Hands-on experience in product failure investigation and report compilation.
- Proficient in English, both written and verbal communication skills.
- Demonstrates accountability, adaptability, and a genuine eagerness to learn.
- A collaborative team player with a positive attitude and strong work ethic.