Deskripsi Pekerjaan
Are you a detail-oriented Quality Engineering professional looking to make a global impact? Masimo, a world-leading medical technology innovator, is seeking a talented Quality Engineer to join our manufacturing team in Pasir Gudang, Johor. In this role, you will be the guardian of our product excellence, ensuring that every medical device we produce meets the highest standards of safety, efficacy, and quality compliance.
As a Quality Engineer, you will bridge the gap between technical design and mass production, providing critical quality input throughout the manufacturing lifecycle. You will collaborate with cross-functional teams to identify potential risks, implement corrective actions, and drive continuous improvement initiatives. If you are passionate about medical technology and dedicated to precision manufacturing, we want to hear from you.
Tanggung Jawab
- Provide technical quality oversight throughout the product manufacturing process to ensure compliance with medical device regulations (ISO 13485, FDA 21 CFR Part 820).
- Perform root cause analysis (RCA) for non-conformances and drive the implementation of effective Corrective and Preventive Actions (CAPA).
- Conduct regular process audits to identify areas for improvement in production efficiency and quality stability.
- Collaborate with R&D and Manufacturing teams to develop and validate test methods and inspection criteria.
- Manage quality documentation, including Standard Operating Procedures (SOPs), quality manuals, and batch records.
- Lead continuous improvement projects focusing on yield optimization and defect reduction through Six Sigma or Lean methodologies.
- Support internal and external audits by preparing necessary data and evidence of compliance.
Kualifikasi
- Bachelor’s degree in Engineering (Mechanical, Electrical, Manufacturing, or Biomedical) or a related technical field.
- Minimum of 2-4 years of professional experience in a Quality Engineering role within a regulated manufacturing environment (Medical Device or Automotive industry preferred).
- Strong working knowledge of ISO 13485, GMP, and quality management systems.
- Proficiency in statistical process control (SPC), FMEA, and root cause analysis tools.
- Strong analytical and problem-solving skills with a data-driven mindset.
- Excellent communication skills in English and Bahasa Malaysia to effectively collaborate with global teams.
- Ability to interpret technical drawings and specifications with high attention to detail.