Flex Supplier Auditor 

Malaysia, Johor 

1660105

Corporate Supplier Auditorlocated in

What a typical day looks like:

• Supplier Qualification--- Follow the supplier qualification process for PSL suppliers through a full supplier qualification audit that embraces: supplier risk assessment, supplier self-assessment, onsite qualification audit, qualification database management.
• Ensures accurate data collection.
• Conducts supplier audits following regulatory, industry and internal quality guidelines including ISO.
• Conducts process audits and follow up closure of open audits.
• Helps department in the root cause investigation and corrective actions of audits findings, tracking to resolution.
• Initiates product/process improvements.
• Helps filing of audits and maintenance of records.
• Monitors and report metrics to meet business needs.
• Prepares investigation of and reports on audit results for follow up on areas of concern.
• Cross communication with GCMs
• Audit schedule planning
• Audit budget investigation and control
• May provide process training to suppliers.
• Help the Global Auditor Certification Program through trainings to the applicants
• Help Maintenance Audit---Help the specific time frame maintenance audit for existing suppliers with SQE. (Every 3 years or controling Supplier Risk)
• Help Supplier CIP (Continuous Improvement Program) --- Improve the supplier performance trough follow up corrective action/audits
• Has knowledge of a company's manufacturing process, applications and process development in order to actively work with suppliers in improving quality systems.
• Provides cross functional help to select, approve and develop suppliers to meet customer and business needs.
• Conduct regular documentation session for updates training material, procedures, etc
• Corporate industry reports through data collection and investigation

The experience we’re looking to add to our team:

• Typically requires a Bachelor’s Degree or equivalent experience
• Minimum 3 years related working experience
• Working knowledge of product risk management standards and tools (e.g. ISO 14971, IATF 16949, FMEA)
• Expertise/experience in problem solving with quality tools such as: 6-sigma / 8-D / CAPA / FMEA/ 5WHY/ Core tools/ VDA, etc.
• FDA CFR Part 820 and/or ISO 13485 knowledge
• Test method validation and gage R&R studies, PPAP
• RBA
• ISO 13485 Lead auditor certifications
• ISO 13485, FDA cGMP, MDD

Required Skills:

Optional Skills: