Manager - Quality

Mativ is a global leader in specialty materials headquartered in Alpharetta, Georgia. The company offers a wide range of critical components and engineered solutions that connect, protect, and purify our world. This role supports Mativ’s Healthcare & Wellness business, providing strong leadership of the site’s Quality function while collaborating with other Quality and Regulatory personnel to support global best practices.

About the role

The Quality Manager will drive and maintain Quality excellence at the Orangeburg, New York site, leading by example and promoting a culture of Quality. This on-site position reports directly to the US Quality Management Team Lead for Healthcare & Wellness.

Responsibilities

• Oversee all aspects of the site’s Quality functional areas, including Quality Engineering, Quality Control, Quality Inspection, and Document Control.
• Provide strong leadership and direction to Quality team members, including staff management, training, development, mentoring, and coaching.
• Set goals and objectives for Quality personnel, ensuring alignment with strategic imperatives and facilitating succession planning.
• Serve as a key member of the Orangeburg Plant Leadership Team, defining, implementing, and supporting growth and improvement projects.
• Communicate effectively with internal and external functions, including Regulatory, Operations, Supply Chain, Finance, Health & Safety, Human Resources, Research & Development, Commercial, and external partners.
• Manage and maintain the Quality Management System (QMS) to ensure compliance with applicable standards and regulations, including ISO 13485:2016 and FDA 21 CFR Part 820, acting as the site’s Management Representative.
• Lead the Management Review process, reporting to top management on the suitability, adequacy, and effectiveness of the QMS and identifying areas for improvement.
• Coordinate and host Certification Body Audits, Regulatory Agency Inspections, and Customer Audits, managing follow-up actions to ensure on-time completion.
• Provide Quality oversight for all aspects of product realization, including authoring, review, and approval of technical documentation.
• Promote awareness of best industry practices and make Quality-related decisions daily.
• Deliver training on Quality-related topics where improvement or additional support is identified.
• Maintain and improve Quality through ownership of the site’s Internal Audit program, customer feedback processes, customer complaints system, control of non-conforming product, and corrective actions.
• Develop, maintain, and monitor Quality Key Performance Indicators (KPIs) and metrics to identify areas for improvement and measure progress.
• Maintain a customer excellence mindset to achieve satisfaction, manage customer relationships, and ensure customer requirements are documented and followed.
• Ensure Quality participation and input into Risk Management activities, including tools such as pFMEAs.

Requirements

• Bachelor’s degree in science or engineering (or equivalent).
• At least 5+ years of experience in Quality Management, preferably in the medical device and/or pharmaceutical industry.
• Thorough understanding of ISO 13485 and FDA 21 CFR 820.
• Knowledge of FDA 21 CFR 210 & 211 and MoCRA Requirements.
• Knowledge of ISO 14971 standard.
• Certified Lead Audit qualification.
• Substantial front-room experience with FDA Inspections and Certification Body Audits.

Preferred Qualifications

• Lean Six Sigma Green Belt Certification.

Skills

• Demonstrated ability to manage a Quality team in an operational environment.
• Strong leadership skills, including change management.
• Highly motivated and self-directed, with the ability to work in a matrix reporting environment.
• Strong communication skills (verbal and written) for all levels of management.
• Detail-oriented, excellent organizational skills, and diligent.
• Strong interpersonal skills and ability to collaborate within and across teams.

Benefits

Mativ benefits are designed to support employees and their families with high-quality, competitive, and affordable choices across many levels. Offerings reflect our commitment to caring for each other.