Quality Engineer

Location: Bayan Lepas, Penang

Job Descriptions:

• 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.

Job Requirements:

• Bachelor’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.
• 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.

Others Information:

For those who have what it takes, please send in resume to: Recruitment Consultant : Lara Email : lara@brightprsopect.com.my