Quality Systems Manager, Medical Devices

Company Description

ALM Ortho, Inc. develops advanced patient-matched orthopedic implants using EBM, a cutting-edge additive manufacturing technology. Employing innovative and integrated design software, the company significantly accelerates the delivery of customized orthopedic solutions tailored to each patient’s anatomy. Focused on addressing complex cases unmet by standard products, ALM Ortho stands out in the market, offering unmatched expertise and innovative solutions. With a streamlined approach, the company prioritizes surgeon and patient needs, delivering high-quality, patient-specific devices efficiently and effectively. Our mission is to restore mobility, independence, and long-term quality of life for individuals experiencing limb loss or severe musculoskeletal injury.

Role Description

This is a full-time, on-site role located in Scarborough, ME, for a Quality Systems Manager, Medical Devices. The role involves leading and managing the development, implementation, and continuous improvement of quality systems to ensure regulatory compliance with medical device standards. Day-to-day responsibilities include overseeing documentation, facilitating audits, coordinating cross-team quality initiatives, and ensuring product quality standards. The manager will be critical in maintaining certifications, managing audits, and fostering a culture of quality throughout the organization.

Qualifications

• Proven experience in Quality Systems Management and Quality Assurance within the medical device or related industries
• Strong understanding of regulatory standards and compliance processes, including ISO 13485, FDA regulations, and CE marking requirements
• Proficiency in risk management principles, quality system development, and implementing corrective and preventive actions (CAPA)
• Excellent communication, leadership, and project management abilities
• Detail-oriented with skills in documentation, audit preparation, and process improvement methodologies
• Bachelor’s degree in Engineering, Life Sciences, or a related field; advanced certifications in quality or regulatory affairs are a plus
• Knowledge of patient-matched orthopedic devices and additive manufacturing is advantageous
• Ability to work collaboratively in an on-site team setting to ensure product quality and compliance
• Coordinate verification/validation test plans with design engineers.
• Support regulatory submissions and communication with notified bodies or FDA.
• Train internal teams and reinforce a culture of patient safety and continuous improvement.

·       Mission-driven work directly improving patient mobility and outcomes.

·       Opportunity to build and lead scalable quality systems.

·       Collaborative team environment.

·       Competitive compensation and benefits.