Deskripsi Pekerjaan
At Becton Dickinson (BD), we are one of the largest global medical technology companies in the world. Our purpose is to help all people live healthy lives. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do.
We are seeking a meticulous and dedicated Quality Engineer 1 to join our dynamic team in Kulim, Kedah. In this role, you will be the guardian of product and process integrity, ensuring that our innovative medical devices meet the highest regulatory standards and quality benchmarks. You will collaborate cross-functionally to drive continuous improvement, resolve non-conformances, and champion a culture of quality and safety throughout our manufacturing and logistics operations.
From supporting production lines by monitoring critical process parameters to leading root cause analysis for quality excursions, you will be an integral part of bringing life-saving technologies to patients and healthcare providers around the globe. If you are passionate about quality and motivated by a purpose-driven mission, this is your opportunity to make a tangible impact on human health at one of the world's most respected medical technology companies.
Join us in Kulim and play a key role in our global supply chain. Be part of something bigger. Be part of BD.
We are seeking a meticulous and dedicated Quality Engineer 1 to join our dynamic team in Kulim, Kedah. In this role, you will be the guardian of product and process integrity, ensuring that our innovative medical devices meet the highest regulatory standards and quality benchmarks. You will collaborate cross-functionally to drive continuous improvement, resolve non-conformances, and champion a culture of quality and safety throughout our manufacturing and logistics operations.
From supporting production lines by monitoring critical process parameters to leading root cause analysis for quality excursions, you will be an integral part of bringing life-saving technologies to patients and healthcare providers around the globe. If you are passionate about quality and motivated by a purpose-driven mission, this is your opportunity to make a tangible impact on human health at one of the world's most respected medical technology companies.
Join us in Kulim and play a key role in our global supply chain. Be part of something bigger. Be part of BD.
Tanggung Jawab
- Monitor and ensure quality standards for high-volume medical device manufacturing and logistics processes in the Kulim plant.
- Lead and support investigations into non-conformances, customer complaints, and drive effective CAPA (Corrective and Preventive Actions).
- Conduct internal and supplier audits to maintain compliance with ISO 13485, MDSAP, and FDA QSR regulations.
- Support the qualification and validation of new production equipment, test methods, and processes (IQ/OQ/PQ).
- Analyze statistical process control (SPC) data to identify trends, reduce variability, and drive continuous process improvements.
- Collaborate with cross-functional teams (Operations, Supply Chain, R&D) to resolve quality issues and support product launches.
- Create, review, and update Quality System documentation including SOPs, Work Instructions, PFMEAs, and Control Plans.
- Participate actively in Lean and Six Sigma initiatives to foster a culture of zero defects and operational excellence.
Kualifikasi
- Bachelor's degree in Mechanical, Electrical, Chemical, Biomedical Engineering, or a related technical field.
- 1–3 years of relevant experience in a Quality Engineering role within a regulated industry (medical device, pharmaceutical, or high-tech manufacturing preferred). Fresh graduates with strong internship experience are welcome.
- Solid understanding and application of quality management systems (ISO 13485, FDA 21 CFR 820, or ISO 9001).
- Hands-on experience with statistical analysis and problem-solving tools (Minitab, JMP, FMEA, Root Cause Analysis, 8D).
- Knowledge of validation principles (Installation Qualification, Operational Qualification, Performance Qualification).
- Strong analytical, communication, and interpersonal skills with the ability to work effectively in cross-functional teams.
- Detail-oriented with a proactive approach to identifying and resolving quality challenges.
- Must be willing to work in Kulim, Kedah.