Engineer, Quality Engineering
- Pulau Pinang
- Permanent
- Full-time
- The Quality Engineer plays a vital role in driving business improvements by supporting process and product characterizations, applying lean methodologies like Six Sigma, and conducting benchmarking for continuous improvement. This includes supporting quality engineering skill development for new product introductions and throughout the product life cycle.
- A key part of the role is ensuring compliance with global regulatory standards such as FDA 21 CFR, ISO13485, and regional medical device regulations. The Quality Engineer is responsible for internal and external audit readiness, conducting line audits, and supporting corrective and preventive actions for any compliance gaps.
- Additionally, the role involves active engagement in product and process validation (IQ, OQ, PQ), quality control, complaint handling, and risk mitigation. The Quality Engineer partners closely with cross-functional teams, suppliers, and manufacturing to ensure effective process controls, quality metrics tracking, and the implementation of robust control plans that align with patient safety and regulatory requirements.
- This Quality Engineer position is a great opportunity for fresh graduates with a degree in Engineering or a related technical field to begin their careers in the medical device industry. While prior experience in FDA or European regulatory environments is beneficial, it is not mandatory. The role offers hands-on exposure to manufacturing operations, process validation, and the application of industry standards such as ISO 13485 and FDA 21 CFR. Fresh graduates are encouraged to apply and will receive guidance and training as they grow into the role.
- Candidates should have a strong interest in quality systems, risk management, and continuous improvement methodologies such as Lean, Six Sigma, and Statistical Process Control. The role involves analyzing data, troubleshooting, and supporting new product introductions. Effective communication, analytical thinking, and basic statistical knowledge will be advantageous for success in this position. Training and mentorship will be provided to help develop these skills over time.
- The position is based in Batu Kawan, Penang, and offers a balanced work environment with opportunities for career growth. It requires occasional physical tasks such as walking, taking measurements, and visual inspections, but primarily involves computer-based work. The ideal candidate is eager to learn, detail-oriented, and motivated to contribute to a high-performing quality team in a dynamic and regulated industry.