Supplier Quality Manager

About the role

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.

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;
• Maintain validation processes concerning sterilization and production at suppliers;
• 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.

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);
• 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).

Skills

• 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

At Essity, we offer:

• Competitive annual salary + annual incentive bonus + benefits;
• United Healthcare PPO / EyeMed Vision Insurance / Delta Dental Insurance;
• Wellness program provided through RallyHealthcare 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.

Additional Information

The Company is committed to equal employment opportunity and providing reasonable accommodations to qualified candidates and employees pursuant to applicable law. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, sexual orientation, physical or mental disability, medical condition, military and veteran status, gender identity or expression, genetic information, or any other characteristic protected by federal, state, or local law.