Job Description
Responsibilities: Maintain accurate and up-to-date ISO 9001, ISO 14001, and ISO 13485 documentation, including Quality Manuals, procedures, work instructions, and records, to ensure system compliance and management review readiness. Plan, coordinate, and conduct internal and external audits to ensure organizational readiness for third-party certification, management reviews, and customer audits. Collaborate with internal stakeholders to support and participate in customer and supplier audits to ensure compliance requirements are met. Review audit findings, develop corrective action plans, and drive continuous improvement initiatives. Generate and review supplier quality performance reports, work closely with suppliers to resolve non-conformances, and promote continuous improvement. Issue, monitor, and follow up on Supplier Corrective Action Requests (SCAR), ensuring effectiveness and timely closure. Support qualification and onboarding of new suppliers to maintain a robust pipeline ali...