Supplier Quality Manager

Essity • Charlotte, NC

3d • Onsite

About The Position

Essity Health and Medical Solutions is currently seeking a Supplier Quality Manager. This position will be located at our facility in Charlotte, NC. This person will assure sustainable quality and deliver benefits to the supply chain by pro-active support and close collaboration with the Bought-In-Finished-Good (BIFG) suppliers as well as by securing continuous supplier monitoring and improvement activities. They will also ensure quality and regulatory compliance of the BIFG suppliers.

Requirements

• 5+ years experience in quality assurance/quality management preferably at medical device manufacturers, pharmaceutical or automotive companies
• Experienced and certified (supplier) auditor
• Knowledge of modern tools and application in continuous improvement projects (Six Sigma Green or Black Belt certification)
• Excellent communication and influencing skills
• Big picture orientation
• Assertiveness
• Demonstrated ability to work in a matrixed environment
• Ability to achieve results through problem-solving, decision making, prioritization, organization, and time management
• Experience in developing strong and effective interpersonal relationships with a range of external and internal stakeholders
• Engineering or Life Science related bachelor’s degree
• Business fluent in English (verbal and written)
• Software knowledge: MS Office, DocuSign, electronic QMS systems

Nice To Haves

• Prefer knowledge of quality system standards, laws, and regulations such as ISO 13485, ISO 14971, US-FDA QSRs, EU – MDR, GxPs
• Knowledge of AI applications in supplier quality management, such as predictive analytics for quality control and automation of routine tasks

Responsibilities

• 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 approved supplier list
• 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

Benefits

• Competitive annual salary
• annual incentive bonus
• United Healthcare PPO / EyeMed Vision Insurance / Delta Dental Insurance
• Wellness program provided through Rally
• Healthcare and 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior