Quality Manager

Job Title: Quality Manager – Medical Technologies The Quality Manager for Medical Technologies plays a critical role in ensuring quality and regulatory compliance across the entire product lifecycle, from initial design and supplier materials to manufacturing processes and finished medical devices. This role maintains and enhances the Quality Management System (QMS) in alignment with FDA 21 CFR Part 820 and other applicable medical technology regulations, while driving continuous improvement initiatives. The Quality Manager manages supplier quality performance, supports design transfer, and contributes to post-market surveillance to ensure the safety, efficacy, and reliability of innovative medical technologies within a dynamic startup environment. Responsibilities Serve as the company’s Quality Management Representative and act as the primary point of contact for quality-related matters. Collect, analyze, and report relevant quality key performance indicators (KPIs) and lead management review meetings to drive data-based decision-making. Ensure continued compliance of the Quality Management System (QMS) with FDA 21 CFR Part 820 (Quality System Regulation) and other applicable international medical technology regulations. Develop, implement, and maintain quality procedures, work instructions, and documentation related to operations and supplier quality. Plan, conduct, and document internal audits to verify QMS effectiveness and identify opportunities for improvement. Support and participate in external audits, including supplier audits and customer audits, ensuring timely response to findings and corrective actions. Actively participate in risk management activities throughout the product lifecycle, including hazard analyses and design and process risk assessments. Ensure identified risks are effectively mitigated and controlled within operations and throughout the supply chain. Monitor and control manufacturing processes to ensure product quality, consistency, and compliance with design specifications and regulatory requirements. Lead and participate in Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) investigations for manufacturing nonconformances, deviations, and customer complaints. Support, review, and approve process validation activities (IQ, OQ, PQ) for new and existing manufacturing equipment and processes. Implement and maintain Statistical Process Control (SPC) techniques to monitor and manage critical process parameters. Drive continuous improvement projects within manufacturing operations using Lean, Six Sigma, and other quality methodologies. Review and approve manufacturing batch records and Device History Records (DHRs) to support product release decisions. Collaborate closely with cross-functional teams, including design, operations, and supply chain, to ensure robust design transfer and ongoing product quality. Manage supplier quality performance, including qualification, auditing, and ongoing oversight, to ensure consistent delivery of compliant materials and components. Communicate effectively with internal stakeholders and external parties such as suppliers and auditors to align on quality expectations and outcomes. Contribute to a culture of quality and continuous improvement within a fast-paced medical technology startup environment. Essential Skills Bachelor’s degree in Engineering (such as Biomedical, Mechanical, Electrical, or Industrial), Quality Management, or a related technical field. 5–7 years of progressive experience in quality engineering, quality assurance, and/or related quality roles within the medical or regulated manufacturing industry. In-depth knowledge and hands-on experience with FDA 21 CFR Part 820 (Quality System Regulation). Experience working within regulated medical technology or medical device manufacturing environments and understanding of applicable international regulations. Experience with risk management activities and standards in a medical technology context, including conducting hazard analyses and risk assessments. Demonstrated experience with medical technology manufacturing processes and process controls. Proficiency with quality tools and methodologies such as Root Cause Analysis (RCA), Corrective and Preventive Action (CAPA), Failure Modes and Effects Analysis (FMEA), Control Plans, Statistical Process Control (SPC), Gauge R&R, and Design of Experiments (DOE). Experience with supplier qualification, auditing, and ongoing supplier management in a regulated environment. Strong analytical, problem-solving, and critical thinking skills applied to complex quality and manufacturing challenges. Excellent written and verbal communication skills, with the ability to interact effectively with all levels of the organization and external stakeholders including suppliers and auditors. Ability to work both independently and collaboratively in a dynamic, fast-paced medical technology environment. Proficiency in Microsoft Office Suite, including Excel, Word, and PowerPoint. Additional Skills & Qualifications Experience with ERP systems to support manufacturing, quality, and supply chain processes. Experience using electronic Quality Management System (eQMS) software. Certified Quality Engineer (CQE) or similar professional quality certification. Lean Six Sigma training or certification, including Green Belt or Black Belt credentials. Prior experience in a startup or early-stage medical technology environment. Demonstrated ability to lead cross-functional continuous improvement initiatives. Interest in working with cutting-edge medical technologies such as electromagnetic tracking platforms. Work Environment The role is based in a growing medical technology startup environment located within a multi-room facility in the UEL building in St. Paul, Minnesota. The site currently consists of four rooms, including dedicated office space for administrative and engineering work, an assembly area for hands-on manufacturing and product build activities, and shelf space for storing and staging final products. The current team is approximately eight people, offering close collaboration with experienced colleagues and the opportunity to shape processes and culture as the organization expands. As the company grows, there is potential to build out the existing space further and eventually move to a larger location. The environment is dynamic, fast-paced, and innovation-focused, providing exposure to advanced medical technology development and the full product lifecycle. Job Type & Location This is a Permanent position based out of Saint Paul, MN. Pay And Benefits Healthcare: Comprehensive health, dental, and vision insurance with Flexible Spending Accounts (FSA) and mental health coverage. Financial & Retirement: 401(k) retirement plan, Employee Stock Purchase Plan (ESPP), and company equity opportunities. Work-Life & Family: Generous parental leave and paid time off. Additional Perks: Emotional wellness programs and, depending on the office location, social events and on-site perks. Application Deadline This position is anticipated to close on Aug 7, 2026. #J-18808-Ljbffr