Quality Manager

Job Description

Join Our Team at HuFriedyGroup – Innovating Excellence in Dental Instrument Manufacturing :

HuFriedyGroup is a leading manufacturer of dental instruments and infection prevention products. Our 10,000-plus products, hand-crafted by highly skilled artisans, are known for their precision, performance, longevity, reliability, and quality. To help dental professionals be The Best in Practice, HuFriedyGroup provides a unique combination of world-class products, value-added services, clinical education, and dental community platforms that result in superior clinician performance and enhanced safety for dental professionals and their patients. Working at HuFriedyGroup is more than a job; every employee plays a part in driving our vision to be a global leader in advancing dental performance through Best-In-Practice dentistry that improves lives worldwide.

Summary of Position

The Quality Manager is responsible for leading quality improvement initiatives within a manufacturing or service facility. This role involves implementing and maintaining state-of-the-art quality practices for product and service lines, ensuring compliance with domestic and international standards such as ISO 9001, ISO 13485, MDSAP, CFR Part 820 / 211, and EU MDR. The Quality Manager oversees quality system organization, documentation, and compliance, leading efforts in product / service quality, supplier quality, process quality, and new product development quality. The role also serves as the Management Representative for the site, ensuring the quality system meets all regulatory standards.

• Lead the Quality team to ensure compliance and continuous improvement.
• Align quality initiatives with manufacturing and service operations, supporting Lean efforts.
• Collaborate with senior management to develop quality strategies.
• Provide input on future product and service development from a quality perspective.
• Coach and mentor Quality staff.
• Serve as Management Representative and lead Management Review.
• Ensure regulatory compliance.
• Drive continuous improvement through data analysis and process enhancements.
• Manage production controls and complaint handling processes.
• Ensure compliance with New Product Development procedures and quality metrics.
• Assess manufacturability, testability, and reliability of new designs.
• Evaluate supplier qualification risks.
• Perform regulatory compliance duties, including acting as Person Responsible for Regulatory Compliance under EU MDR.
• Perform additional duties as assigned.

Knowledge, Skills & Abilities :

Benefits :

HuFriedyGroup is an equal opportunity employer committed to diversity and inclusion. We prohibit discrimination and harassment of any kind. For accommodations during the application process, contact us at 773-868-5534. We support you throughout your journey with HuFriedyGroup!

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