Senior Supplier Quality Engineer — GMP/ISO Compliance

AMS; Kulim; On-site; MYR 50,000 - 70,000; Full time

Job summary

A leading engineering company in Kedah, Malaysia is seeking a quality engineer to ensure supplier quality and promote compliance with industry standards. The ideal candidate will hold a Bachelor's degree with over 4 years of engineering experience, particularly in regulated environments. Responsibilities include monitoring supplier performance, conducting audits, and providing technical support. Strong communication skills and proficiency in English are essential for this role which involves collaboration with multidisciplinary teams worldwide.

Qualifications

• 4+ years of relevant engineering experience.
• Experience in regulated environments like medical devices or pharma.
• Intermediate-advanced English proficiency.

Responsibilities

• Ensure suppliers deliver quality parts and services.
• Qualify suppliers and administer a Certified Supplier Program.
• Monitor parts through the manufacturing cycle.
• Audit designated suppliers for GMP and quality standards.
• Provide technical guidance for Supplier Quality engagement.

Skills

Problem-solving

Supplier performance monitoring

Effective communication

Critical thinking

Collaboration skills

Technical documentation

CAD (SolidWorks, AutoCAD)

Knowledge of manufacturing processes

Knowledge of ISO 13485

Knowledge of GMP

Education

Bachelor’s Degree in engineering (biomedical, chemical, industrial, biotechnology, mechanical or related)

Job description

A leading engineering company in Kedah, Malaysia is seeking a quality engineer to ensure supplier quality and promote compliance with industry standards. The ideal candidate will hold a Bachelor's degree with over 4 years of engineering experience, particularly in regulated environments. Responsibilities include monitoring supplier performance, conducting audits, and providing technical support. Strong communication skills and proficiency in English are essential for this role which involves collaboration with multidisciplinary teams worldwide.