Quality Engineer

Bright Prospect; Bayan Lepas; On-site; MYR 40,000 - 60,000; Full time

Job summary

A prominent consulting agency is looking for a Quality Engineer based in Bayan Lepas, Penang. The successful candidate will apply engineering principles to ensure product quality, conduct inspections, and perform root cause analysis. Candidates should have a Bachelor’s degree, and openness to fresh graduates or those with some experience in quality engineering is desired. This is a 1-year contract position, and strong analytical and communication skills are required.

Qualifications

• Open to fresh graduates or candidates with average 2 years experience in quality engineering.
• Basic understanding of quality tools and methodologies is required.
• Familiarity with ISO 13485 and FDA QSR is a bonus.

Responsibilities

• Apply quality engineering principles to analyze quality records and recommend improvements.
• Conduct inspection, verification, and validation of components or materials.
• Support root cause analysis and corrective/preventive actions.

Skills

Analytical skills

Problem-solving skills

Communication skills

Documentation skills

Teamwork

Education

Bachelor’s degree in engineering or science

Tools

Microsoft Office (Excel, Word, PowerPoint)

Quality systems software

Job description

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.
• 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.
• Willing to work for 1 year contract

Other Information

For those who have what it takes, please send in resume to:

Recruitment Consultant : Lara

Email : ****@brightprsopect.com.my

Agensi Pekerjaan & Perundingcara Bright Prospect Sdn Bhd

Lot No.28-03, 28th Floor, Public Bank Tower,
No.19, Jalan Wong Ah Fook, 80000 Johor Bahru, Johor.
Tel : [phone]

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