Supplier Quality Manager

Essity AB; Charlotte (NC); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health benefits

401(k) with match

Paid holidays

Job summary

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.

Qualifications

• 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.

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 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.

Skills

Quality assurance

Auditing

Supplier management

Continuous improvement

Communication skills

Education

Bachelor's degree in Engineering or Life Sciences

Tools

MS Office

QMS software

DocuSign

Job description

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.

What You Will Do

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.

Who You Are

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;

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. Knowledge of AI applications in supplier quality management, such as predictive analytics for quality control and automation of routine tasks.

What We Can Offer You

At Essity, we believe every career is as unique as the individual and empower employees to reach their full potential in a winning culture motivated by a powerful purpose.

Compensation and Benefits:

Expected Compensation:

Competitive annual salary + annual incentive bonus + benefits.

Pay offered may vary depending on multiple individualized factors such as knowledge, skills, and experience.

Along with competitive pay you will be eligible for the following benefits:

• 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.

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.

Together, we are improving lives, every day

Working at Essity is not just a career; it is a chance to directly make the world a healthier, more hygienic and safer place. With impactful innovations coupled with sustainable solutions, we strive to reach more people every year with the necessary and essential solutions for well-being.