Quality Engineer - Penang

Location

Penang, Malaysia

Alleima Business Unit (BU) Medical produce and sell components for life changing medical devices. We are on an exciting growth journey and have made three acquisitions and set up two greenfield sites within the last four years. Being a truly global organization, we have manufacturing sites in Germany, Switzerland, and Italy as well as in the USA. We are now expanding into Malaysia and setting up a new production site in Penang. The site will initially be very small, but we are looking to grow within the coming years.

We are now looking for a quality engineer for our new site.

Your Role

In this role you will start by working together with the project manager, production unit manager and engineering colleagues in the USA to ensure the quality program is implemented and successful. This will require travelling to the USA and other locations. Once we are up and running your expertise will be crucial in developing our capabilities.

Key responsibilities:

Develop and implement documentation, procedures, and work instructions to support the quality management function.

Manage customer complaints, internal nonconformances, and internal action items, including root cause analysis, identification of corrective and preventive actions, and reporting.

Support the development of quality requirements for new product introduction, while assisting in the development, review and approval of process and equipment qualifications (IQ,OQ,PQ,PV)

Support the development of new and existing product programs to ensure program expectations are met.

Perform regular reporting on quality management system measurables.

Manage the internal audit program, including performing internal audits, audit reporting, and ensuring that resulting action items are initiated, effective, and completed.

Support the quality management function for customer and certification body audits.

Supplier development and support, which includes development programs to meet and/or correct performance to meet quality requirements. Supplier performance monitoring, including supplier audits to ensure conformity to requirements.

Support and develop technical program to monitor certifications and inspection of equipment and materials.

Support environmental, health and safety initiatives.

About You

Candidates with a bachelor’s degree in engineering and/or equivalent degree or five years’ experience in quality engineering. An ideal candidate will have in-depth knowledge of quality management systems, such as ISO 13485 & ISO 9001, manufacturing processes, internal auditing, six sigma principals, root cause analysis, and data analysis proficiency in Minitab, and Health and safety

What you can expect from us

We offer an interesting role within a growing company with good future prospects and opportunities for further development. With our global footprint you will collaborating closely with your colleagues in the USA and Europe.

Additional Information

Your direct manager will be based in Penang. Apply for the role at

At Alleima, our mission is much more than delivering high-quality products, technology, and processes - working together to develop solutions based on our customer’s needs and thus achieve our business goals, is a better way to describe our daily work. With curious employees and safety as our priority, we create a work environment where you can develop both personally and professionally.

With a clear direction for our journey ahead, utilizing our position as a technology leader, progressive customer partner, and sustainability driver, we aim to become an even stronger company in our industry.

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