Hiring: Manager, Quality Systems Company: STERIS Location: Minneapolis, MN Job Posted Time: 2026-09-10 14:38:31 Employment Type: On-site Target Skills & Keywords : Microsoft Excel, Microsoft PowerPoint, Regulatory Compliance About the job Experience: •10 years working in an ISO Certified (ISO 13485 strongly preferred) environment. •10 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience. •10 years of experience working in an ISO certified environment required. •2 years in a Quality leadership role. •10 years of experience with medical device or other regulated industries preferred. Required Skills: •The Quality Manager in our Coon Rapids, MN in our •Facility is responsible for leading quality improvement for an AST processing or lab facility. This position leads implementing and maintaining state-of-the-art quality practices and assumes overall responsibility in ensuring that the site maintains operational and quality systems in a state of compliance to domestic and international standards. •ISO 9001, ISO 13485, FDA 21 CFR Part 820/211, EU GMPs, ISO 17025, ISO 11137 and/or ISO 11135 and other applicable regulatory standards. •The Quality Manager has the responsibility, duty and decision-making authority to put any product on hold that is identified as potentially non-conforming and escalating as needed for additional reviews by Technical teams. •This position requires working onsite in our Coon Rapids, MN location Monday through Friday 8am to 5 pm. •NOTE: To be considered for this role you must have a minimum of 10 years working in an ISO Certified (ISO 13485 strongly preferred) environment. •Lead the organization’s Quality staff to ensure compliance to the overall Quality Management System and drive continuous improvement. •Lead the organization’s Quality staff to ensure alignment to operations, support Lean efforts and drive quality improvement for products and services. Qualifications: •Minimum of 10 years of experience with medical device or other regulated industries preferred. •Solid functional working knowledge of FDA QMSR/ EUGMP regulations strongly preferred. •Focus on identification of potential issues and continuous improvement. •Effective interpersonal skills, ability to work independently under minimal guidelines and supervision. •Demonstrated excellent organizational, oral and written communications skills. •Demonstrated capacity to work in a fast-paced, regulated environment with strict deadlines and ever-changing responsibilities. •Mathematical skills including practical application of fractions, percentages, ratios, proportions and algebra. •We value our employees and are committed to providing a comprehensive benefits package that supports your health, wellbeing, and financial future. Compensation: •$115,000 - $130,000 / year •Competitive benefits and rewards package •Extensive Paid Time Off and added Holidays Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!