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Quality Engineer
Abbott Penang (Formerly Known as St. Jude Medical)Bayan Lepas, Pulau Pinang, Malaysia2 hari lalu
Penerangan pekerjaanBachelor's degree in engineering or science principles. Open to fresh grad or within average of 2 years of experience in quality engineering or related field; internship or co-op experience in medical devices or regulated industry is an added advantage. Basic understanding of quality tools and methodologies (e.g., 5 Whys, Fishbone Diagram, FMEA, SPC). Familiarity with ISO 13485 and FDA QSR is an advantage. Strong analytical and problem-solving skills. Good communication and documentation skills. Proficient in Microsoft Office (Excel, Word, PowerPoint); experience with quality systems software is a plus. Ability to work independently and in a team-oriented environment.
Job Description
- Apply quality engineering principles to analyze quality records, prepare reports, and recommend process or product improvements.
- Conduct inspection, verification, and validation of components or materials used in development and production processes.
- Identify and address recurring quality issues related to product performance.
- Document quality issues, non-conformances, and performance metrics for management review and continuous improvement initiatives.
- Support root cause analysis and corrective / preventive actions (CAPA).
- Assist in maintaining compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulatory requirements.
- Participate in internal audits and support external audits as needed.
- Collaborate with engineering, manufacturing, and supply chain teams to ensure product quality and reliability.
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Quality Engineer • Bayan Lepas, Pulau Pinang, Malaysia
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