Quality Manager

Job Title: Quality Manager This role leads day‑to‑day quality operations in a highly specialized medical device manufacturing environment focused on innovative structural heart technologies. The Quality Manager provides hands‑on leadership for inspection, testing, compliance, and quality activities across complex processes including tissue processing, valve assembly, frame shape‑setting, delivery system fabrication, and cleanroom packaging. You will manage a team of quality engineering and inspection professionals, ensure a continuous state of audit readiness, and support the organization as it advances Class III medical devices through pivotal clinical trials and toward commercial approvals in the U.S., Europe, and Canada. Responsibilities Oversee daily quality control operations, including inspection, testing, and release of raw materials, in-process components, and finished sterile medical devices. Provide rigorous quality oversight for high‑precision tissue‑to‑frame sewing and valve assembly processes to ensure consistent product quality and compliance. Maintain a continuous state of audit readiness across the quality control function, ensuring documentation, traceability, and processing environments meet regulatory expectations. Ensure quality systems, records, and processes comply with FDA regulations, 21 CFR Part 820, applicable ISO standards, and relevant international regulatory requirements. Lead investigations of non‑conformances and deviations, including ownership of NCMRs and CAPA activities, to identify root causes and implement effective corrective and preventive actions. Directly handle failures or anomalies identified during complex valve assembly and sewing operations, ensuring timely resolution and documentation. Manage, mentor, and develop a team of quality engineering and inspection professionals, including resource loading and performance guidance. Partner with quality training functions to maintain specialized training and qualification matrices for valve sewing and assembly personnel. Oversee process and environmental controls, including environmental monitoring, bioburden testing, and cleanroom compliance for tissue fixation, processing, and device assembly lines. Support supplier quality activities by collaborating with supplier quality engineering to manage critical component vendors, resolve supplier corrective actions (SCARs), and define incoming inspection criteria. Apply strong understanding of inspection, testing, process controls, and quality systems to drive continuous improvement in manufacturing quality. Balance hands‑on problem solving with strategic thinking to support both day‑to‑day operations and long‑term quality initiatives. Collaborate effectively across functions to support pivotal clinical trials, commercialization activities, and the delivery of high‑quality products for patients. Contribute to an entrepreneurial culture by adapting to evolving priorities and actively engaging in cross‑functional problem solving. Essential Skills Bachelor’s degree in Engineering, Life Sciences, Quality, or a related technical field. 7+ years of experience in quality control, quality engineering, manufacturing quality, or a related medical device environment. Experience working within FDA‑regulated medical device manufacturing, with a strong understanding of 21 CFR Part 820. Experience with ISO‑based quality management systems in a medical device or highly regulated manufacturing environment. Proven experience leading investigations, managing non‑conformances (NCMRs), CAPA, and conducting root‑cause analysis. Experience managing, mentoring, and developing quality professionals in a manufacturing setting. Strong understanding of inspection methods, testing strategies, process controls, and quality systems within a manufacturing environment. Hands‑on experience in quality engineering, quality management, quality assurance, and quality control. Experience with supplier quality, including working with critical component vendors and supporting SCARs and incoming inspection. Ability to work effectively in a fast‑paced, hands‑on environment while managing multiple priorities. Strong communication and collaboration skills, with the ability to influence and partner across functions. Demonstrated ability to apply risk management, design control, design assurance, validation, and design validation principles in a regulated environment. Additional Skills & Qualifications Experience with Class III medical devices, particularly implantable or structural heart products. Experience with tissue processing, tissue sewing, valve assembly, or other highly specialized medical device manufacturing processes. Experience supporting pivotal clinical trials and commercialization activities for medical devices. Familiarity with MDSAP and international regulatory requirements, including those for Europe and Health Canada. Experience working in cleanroom environments and with environmental monitoring and bioburden testing. Strong leadership and team development skills, with the ability to balance hands‑on problem solving with strategic, long‑term quality planning. Excellent communication and collaboration skills, with the ability to influence stakeholders across multiple functions and levels. Demonstrated ability to thrive in an entrepreneurial environment where priorities can evolve and individuals are expected to take initiative and drive results. Background in engineering disciplines or related technical fields that support medical device design assurance, risk management, and validation activities. Work Environment This position is based on‑site in Maple Grove, MN, within a specialized medical device manufacturing facility. You will work closely with cross‑functional teams in a hands‑on environment that includes tissue processing, valve sewing and assembly, frame shape‑setting, delivery system fabrication, and cleanroom packaging operations. The facility operates under FDA, 21 CFR Part 820, ISO, and international regulatory requirements, with a strong emphasis on environmental monitoring, bioburden control, and cleanroom compliance. The culture emphasizes accountability, curiosity, and shared purpose, offering an entrepreneurial atmosphere where priorities may evolve and team members are encouraged to contribute ideas, roll up their sleeves, and directly influence outcomes. The environment supports professional and personal growth, with a strong focus on developing innovative structural heart technologies that can make a meaningful difference for patients. 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 factors. We recognize that meaningful work is supported by meaningful benefits. That’s why we offer a competitive compensation package along with comprehensive benefits designed to support you and your family’s health, well‑being, and financial future. Medical Dental Vision Flexible Spending Account (FSA) Basic Life 401(k) Retirement Plan Paid Holidays PTO Maternity/Paternity paid leave It is 4C Medical’s policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state or local laws. Workplace Type This is a fully onsite position in Maple Grove,MN. Application Deadline This position is anticipated to close on Sep 10, 2026. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email View email address on click.appcast.io for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools. #J-18808-Ljbffr Actalent