Deskripsi Pekerjaan
Are you a detail-oriented professional passionate about medical device excellence? Masimo, a global leader in innovative noninvasive monitoring technologies, is seeking a motivated Assistant Engineer, Quality to join our high-performing team in Pasir Gudang, Johor. In this role, you will play a pivotal part in maintaining our rigorous quality standards throughout the product lifecycle.
As an Assistant Engineer, Quality, you will work closely with cross-functional teams to ensure that our products meet the highest levels of safety, efficacy, and compliance. You will be responsible for conducting inspections, analyzing quality data, and driving continuous improvement initiatives to enhance our manufacturing processes. If you are a proactive problem-solver with a strong background in manufacturing quality, we invite you to help us improve patient outcomes worldwide.
Tanggung Jawab
- Monitor and evaluate production processes to ensure adherence to established Quality Management Systems (QMS).
- Conduct thorough product quality assurance inspections throughout the lifecycle, from raw materials to finished goods.
- Identify, document, and investigate non-conformances, implementing effective corrective and preventive actions (CAPA).
- Collaborate with production and engineering departments to resolve quality-related issues and optimize manufacturing efficiency.
- Participate in internal and external audits to ensure compliance with medical device industry standards (ISO 13485/FDA).
- Analyze quality performance data and prepare reports for management to support informed decision-making.
- Support the calibration and maintenance of inspection tools and testing equipment.
Kualifikasi
- Diploma or Degree in Mechanical, Electrical, Manufacturing Engineering, or a related field.
- Minimum 1-3 years of experience in a quality assurance or manufacturing role, preferably in the medical device or electronics industry.
- Solid understanding of ISO 13485, GMP, and other relevant regulatory standards.
- Proven ability to interpret technical drawings, schematics, and specifications.
- Proficiency in data analysis tools (Excel, Minitab) and root cause analysis techniques.
- Strong analytical skills with a keen eye for detail and process improvement.
- Excellent communication skills in English and Bahasa Malaysia.
- Ability to thrive in a fast-paced, dynamic manufacturing environment.