Quality Manager Are you passionate about building quality into breakthrough medical technologies? We're seeking a Quality Manager to lead quality operations for an innovative structural heart medical device program advancing through pivotal clinical trials and toward global commercialization. In this highly visible leadership role, you will oversee manufacturing quality, inspection, compliance, investigations, and quality systems while leading a team of quality professionals supporting the production of Class III implantable medical devices.
This is an opportunity to influence product quality, regulatory readiness, and operational excellence while helping bring life-changing cardiovascular therapies to patients around the world. What You'll Do Lead quality operations supporting manufacturing, inspection, testing, and release activities. Ensure compliance with FDA, ISO 13485, MDSAP, and applicable international regulations. Maintain a continuous state of audit and inspection readiness.
Lead investigations involving nonconformances, deviations, complaints, and quality events. Drive CAPA activities from investigation through implementation and effectiveness verification. Partner with manufacturing teams to improve process capability, product quality, and operational performance. Oversee environmental monitoring, cleanroom controls, and manufacturing quality processes. Support supplier quality initiatives, including supplier corrective actions and incoming inspection strategies.
Develop and coach quality engineers and quality inspectors while fostering a culture of accountability and continuous improvement. Monitor quality metrics and identify opportunities to improve efficiency, compliance, and product quality. Collaborate across functions to support clinical, regulatory, and commercialization objectives. Contribute to long-term quality strategy while remaining actively involved in day-to-day operations.
Required Qualifications Bachelor's degree in Engineering, Life Sciences, Quality, or a related technical discipline. 7+ years of experience in Quality Engineering, Quality Assurance, Manufacturing Quality, or Quality Operations within a regulated industry. Experience working in FDA-regulated medical device manufacturing environments. Strong knowledge of quality systems, CAPA, nonconformance management, root cause analysis, and regulatory compliance.
Experience leading investigations and driving corrective and preventive actions. Prior people leadership or team management experience. Strong understanding of manufacturing quality, inspection methods, process controls, and quality improvement methodologies. Excellent communication and cross-functional collaboration skills. Preferred Qualifications Experience supporting Class III or implantable medical devices.
Cardiovascular, structural heart, electrophysiology, orthopedic, neuromodulation, or other complex medical device experience. Experience supporting products through clinical studies and commercialization. Familiarity with MDSAP, EU MDR, and Health Canada requirements. Experience working in cleanroom manufacturing environments. Experience with supplier quality and critical component management. Knowledge of risk management, validation, design controls, and design assurance principles.
Proven success in fast-paced or high-growth medical device organizations. Don't meet every qualification? We encourage you to apply. We value diverse medical device backgrounds and recognize that strong candidates may bring transferable experience from other highly regulated product environments. #ACTmneng26 Job Type & Location This is a Permanent position based out of Maple Grove, MN. Pay and Benefits The pay range for this position is $120000.00 - $145000.00/yr.
Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related