Quality Manager

Description

Job Title: US Quality Manager

Reports To: VP of Quality and Regulatory Affairs

Location: Gunnison, UT (On-Site)

Company Overview

PROTEOR USA is a leading company in the Orthotic & Prosthetic industry, committed to innovation and providing the best outcomes for our customers. With over 100 years of experience, we offer an extensive product portfolio that includes the latest advancements in prosthetic technology. We prioritize the #HumanFirst approach and strive to enable prosthetic wearers to live the life they love.

Job Overview

The US Quality Manager will oversee the Quality activities access all PROTEOR USA sites (Tempe, AZ, Irvine, CA, Whitehall, PA and Gunnison, UT), ensuring the highest standards in supplier quality, R&D, manufacturing operations and complaints processing. The ole involves leading a team to investigate product non-conformances, conducting both internal and external audits, and implementing quality system improvements in the line with industry standards, regulatory requirements, and customer expectations. 

Supervisor Responsibilities:

• Lead the Quality team across multiple locations.
• Provide strategic direction and foster a culture of quality, compliance, and continuous improvements.
• Support professional development and training in quality and regulatory standards.

Requirements

Key Responsibilities and Duties

• Develop and maintain a robust quality management system compliant with GMP, FDA QMSR (21 CFR Part 820), ISO 13485, and MDR 2017/745 standards.
• Lead internal and external audits, including FDA inspections and Notified Body to ensure continuous compliance and improvement of quality systems.
• Oversee supplier qualification, monitoring and performance improvement initiatives.
• Define and approve validation strategies and files for new modified equipment, processes, and test methods. 
• Lead root cause investigations and implement effective corrective and preventive actions (CAPA).
• Ensure proper documentation and maintenance of Device Master Records (DMR) and Device History Records (DMR).
• Ensure all quality activities comply with relevant regulatory and quality standards.
• Collaborate with cross functional teams (R&D, Regulatory, Operations) to ensure quality is embedded throughout the product lifecycle.
• Commitment to upholding the procedural requirements of the company's quality management system.
• Monitor and report on quality metrics and KPI's to global leadership.
• Other duties as assigned.  

Required Skills/Abilities

• Expertise in GMP, FDA 21 CFR Part 820 (QMSR), ISO 13485, and MDR 2017/745.
• Proven experience with FDA inspections and ISO audits.
• Excellent problem-solving skills with a proven record in strategic project management.
• Proficiency in the Windows-based software applications (Word, Excel, PowerPoint).
• Excellent communication and organizational abilities.
• Ability to interpret technical drawings and specifications.
• Strong organizational skills and attention to detail.
• High Level on integrity and strong sense of urgency. 

Education and Experience

• Minimum of 5-7 yeas in Quality Management within the Medical Devices sector, with a preference for medical device industry experience (GMP/QSR and ISO 13485).
• Bachelor's degree in Engineering, Quality Assurance, or a related field. A Master's degree or certification in Quality Management or Engineering preferred. 

Physical Reequipments

• Prolonged periods of sitting at a desk and working on a computer
• Must be able to life up to 25 pounds at time