Supplier Quality Manager

Role Overview

• 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 and seek to harmonize overlapping processes
• Actively participate in audits by the notified body or other authorities
• Manage approved supplier list
• Manage supplier nonconformance/CAPA process to ensure timely resolution
• Quality owner for complaint investigation, disposition, and resolution for supplies
• Implement new quality and regulatory requirements with the supplier
• Strongly cooperate with other departments to solve strategic issues with suppliers
• Prepare and negotiate quality agreements with new suppliers
• Schedule, plan, and execute supplier audits to monitor supplier qualification
• Monitor validation processes concerning sterilization and production at suppliers
• Create, maintain, procure, negotiate and/or check all required supplier documentation
• Support and monitor supplier compliance with sustainability targets
• Provide statistical analysis on supplier performance and ensure regular KPI reporting
• Participate in interdepartmental projects to ensure quality compliance

Requirements

• 5+ years experience in quality assurance/quality management preferably at medical device manufacturers, pharmaceutical or automotive companies
• Experienced and certified (supplier) auditor
• Prefer knowledge of quality system standards, laws, and regulations such as ISO 13485, ISO 14971, US-FDA QSRs, EU – MDR, GxPs
• Knowledge of modern tools and application in continuous improvement projects (Six Sigma Green or Black Belt certification)
• Engineering or Life Science related bachelor’s degree
• Business fluent in English (verbal and written)
• Software knowledge: MS Office, DocuSign, electronic QMS systems
• Knowledge of AI applications in supplier quality management, such as predictive analytics for quality control and automation of routine tasks.

Benefits

• United Healthcare PPO
• EyeMed Vision Insurance
• Delta Dental Insurance
• Wellness program provided through Rally Healthcare
• Dependent Care Flexible Spending Accounts (FSA)
• 401(k) with employer match and annual employer base contribution
• Company paid Basic Life, AD&D, short-term and long-term disability insurance
• Employee Assistance Program
• PTO offering with Paid Holidays
• Voluntary benefits to include: critical illness, hospital indemnity, and accident insurance
• Employee discounts program
• Scholarship program for children of Essity employees.