Coordinate ISO 9001:2015 implementation, manage quality audits, oversee compliance at contract manufacturers, and lead quality improvement initiatives.
Key Accountabilities:
- Coordinate ISO 9001:2015 system across the region and ensure all the documentation in place.
- Lead the implementation of Audit findings across the region (MEAIR).
- Visit 3rd party contract manufacturers to oversee the operational quality compliance as per business requirements.
- Own the contract manufacturers and supplier audit management program.
- Coordinate and review the RCA and CAPA of customer complaints across all the sites/contract manufacturers in the region.
- Lead Risk Assessment program i.e. FMEA of key manufacturing processes across the sites.
- Lead the statistical process control program across the sites and contract manufacturers.
- Lead the review and optimization of Business/Quality Process to make them more effective.
- Review the change management related to product and processes at the sites and contract manufactures to identify the risk and their mitigation plan.
- Own the MIS Dashboard and reporting of Quality Management Performance.
- Planning & execution of internal audits across the sites in region
- Provide QM support (routine tasks) i.e. Quality Inspections, Complaint investigations, supplier rejections etc. to ensure disruption free supplies.
- Drive regional quality improvement plans in collaboration with sites and contract manufacturers.
Top Skills
Audit Findings
Fmea
Iso 9001:2015
Mis Dashboard
Statistical Process Control
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