Supplier Quality Manager

Essity is a global leader in health and hygiene headquartered in Stockholm, Sweden, with a North American headquarters located in Philadelphia, PA. We are a multi-billion-dollar company with a purpose to break barriers to well-being for the benefit of consumers, patients, care givers, and customers across the globe. We do this through innovations in our Professional Hygiene, Consumer Goods, and Health & Medical business units that provide hygiene and health solutions to over a billion people every day worldwide.

Working at Essity is more than a career, it is where you will play your part in a better future, to improve well-being for people and have opportunities to drive positive change for society and the environment. As an employee at Essity, you will belong to a team where you feel valued, are safe, supported to grow and challenged to generate business results in a friendly and open atmosphere.

About the Role

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.

We're looking for people who embody our values, aren't afraid to challenge, innovate, experiment, and move at a fast pace. We're always looking for ways to improve our products and ourselves. If this is you, we'd love to talk.

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.

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…