Supplier Auditor
Flex
full-time
Posted on:
Location Type: Office
Location: Johor • 🇲🇾 Malaysia
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Support supplier development in manufacturing or service processes; work with suppliers to continuously improve performance and implement process controls and quality assurance plans
- Develop and implement quality management procedures and systems
- Plan and coordinate internal process audits and supplier qualification audits
- Conduct supplier audits following regulatory, industry and internal quality guidelines including ISO; conduct process audits and follow up closure of open audits
- Perform root cause investigations, drive corrective actions and track to resolution
- Initiate product/process improvements and help filing audits and maintenance of records
- Monitor and report metrics; prepare investigations and reports on audit results for follow up
- Coordinate cross communication with GCMs, audit schedule planning, audit budget investigation and control
- Provide process training to suppliers and support Global Auditor Certification Program trainings
- Support maintenance audits for existing suppliers (every 3 years or as part of supplier risk control)
- Help Supplier Continuous Improvement Program (CIP) to improve supplier performance
Requirements
- 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
- Knowledge of FDA CFR Part 820 and/or ISO 13485
- Test method validation and gage R&R studies experience; PPAP RBA
- ISO 13485 Lead auditor certification and/or FDA cGMP, MDD (FA22 AN26 mentioned)
- Ability to conduct supplier and process audits and follow up corrective actions
- Knowledge of manufacturing processes, applications and process development
- Ability to prepare audit reports and monitor metrics
- May provide process training to suppliers
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
quality management proceduresprocess auditsroot cause investigationscorrective actionsproduct/process improvementstest method validationgage R&R studiesPPAP RBAproblem solvingsupplier qualification audits
Soft skills
cross communicationtrainingcoordinationreport preparationperformance improvement
Certifications
ISO 13485 Lead auditor certificationFDA cGMPMDD