Global Supplier Quality Leader

Essity AB; Charlotte (NC); Vor Ort; USD 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Health benefits

401(k) with match

Paid holidays

Zusammenfassung

Essity Health and Medical Solutions in Charlotte, NC, seeks a Supplier Quality Manager to ensure sustainable quality across BIFG suppliers and continuous supplier improvement. You will lead quality programs, audits, and regulatory compliance, coordinating with procurement, regulatory, and supply chain teams to resolve strategic issues.

The role requires 5+ years in QA/QMS, supplier auditing, and a bachelor’s in Engineering or Life Sciences, with strong English communication.

Qualifikationen

• 5+ years experience in quality assurance/quality management preferably at medical device manufacturers, pharmaceutical or automotive companies.
• Certified (supplier) auditor.
• Knowledge of quality system standards, laws, and regulations such as ISO 13485, ISO 14971, US-FDA QSRs, EU – MDR, GxPs.

Aufgaben

• Act as role model for safety and quality.
• Ensure continuous improvement of supplier performance.
• Serve as technical leader regarding quality matters for the area of responsibility.
• Lead global SQM best practices, quality systems, and processes.
• Develop policies and procedures, seek to harmonize overlapping or conflicting processes, and identify opportunities for lean processes and documentation.
• Actively participate in audits by the notified body or other authorities.
• Manage supplier nonconformance/CAPA process to ensure timely resolution and effective corrective actions.
• Quality owner for complaint investigation, disposition, resolution, and response for supplies (Raw material and BIFG).
• Implement new quality and regulatory requirements with the supplier.
• Strongly cooperate with other departments (procurement, regulatory, supply chain) to solve strategic issues with suppliers.
• Prepare and negotiate quality agreements with new suppliers and update existing agreements.
• Schedule, plan, and execute supplier audits to monitor supplier qualification.
• Monitor validation processes concerning sterilization and production at suppliers.
• According to requirements create, maintain, procure, negotiate and/or check all required supplier documentation such as quality agreements, current certifications or registrations, assessment reports, and delivery specifications.
• Support and monitor supplier compliance with sustainability targets by ensuring that suppliers comply with our supplier standard and that audit is carried out in “high risk” areas.
• Provide statistical analysis on supplier performance and ensure regular KPI reporting.
• Participate in interdepartmental projects to ensure quality compliance with internal and external requirements.
• Initiate and participate in improvement projects.
• Set-up quality inspection strategy/plans in the system.
• Monitor and support product releases.
• Ensure that products have the required regulatory status.
• Provide quality compliance guidance to 3PLs regarding the handling of returned goods, packaging damages, etc.
• Ensure proper training for quality functions for BIFG inspection related tasks.

Kenntnisse

Quality assurance

Auditing

Supplier management

Continuous improvement

Communication skills

Ausbildung

Bachelor's degree in Engineering or Life Sciences

Tools

MS Office

QMS software

DocuSign

Jobbeschreibung

Essity Health and Medical Solutions in Charlotte, NC, seeks a Supplier Quality Manager to ensure sustainable quality across BIFG suppliers and continuous supplier improvement. You will lead quality programs, audits, and regulatory compliance, coordinating with procurement, regulatory, and supply chain teams to resolve strategic issues.

The role requires 5+ years in QA/QMS, supplier auditing, and a bachelor’s in Engineering or Life Sciences, with strong English communication.