Supplier Quality Manager

Essity•Charlotte, NC

2d•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. 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.

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)
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.

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

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