Maple Grove Senior Quality Systems Engineer MN 55311

Job description

Recruiter: Spencer Gregory Hale Senior Quality Systems Engineer About the role: The Senior Quality Systems Engineer provides technical leadership and subject matter expertise in the development, maintenance, and continuous improvement of the Quality Management System (QMS), ensuring compliance with applicable regulatory requirements and industry standards. This is a hybrid work mode position located in Maple Grove, MN at the Arbor Lakes Site Location with the expectation to be in the office 3 days per week. Your responsibilities include: Lead and support QMS processes including CAPA, nonconforming events, internal audits, external audits and management review. Ensure compliance with applicable regulatory requirements and standards, including FDA QMSR, ISO 13485, ISO 14971, and EU MDR. Mentor teams leading complex investigations, root-cause analysis, corrective actions, and effectiveness verification. Support internal and external audits and regulatory inspections, including site preparation, SME readiness, finding responses, and remediation activities. Analyze quality metrics and trends to identify systemic risks and drive data-based improvements. Lead continuous improvement initiatives to enhance QMS effectiveness, compliance, and operational efficiency. Partner cross-functionally with Engineering, R&D, Regulatory, Operations, and other stakeholders to resolve quality issues and implement sustainable solutions. Develop and maintain quality procedures, work instructions, and other controlled documentation. Apply risk-based decision-making to quality and compliance issues. Serve as a QMS subject matter expert, providing guidance, training, and mentorship to cross-functional team members across the site. Lead quality-system projects and influence stakeholders to ensure timely, compliant, and effective execution. Partner with Global teams to influence and drive continual improvement within the QMS. What we’re looking for in you: Minimal qualifications: Bachelor's degree and 5+ years or Master's degree and 3+ years of experience in a medical device manufacturing, quality or regulatory/compliance environment Understanding of quality system requirements as stated within FDA QMSR, ISO 13485, ISO 14971, and EU MDR Technical writing and documentation skills Attention to detail and ability to analyze information quickly Use a risk-based approach for making quality and business decisions Preferred Qualifications: Proactive, able to work independently, as a team leader or member, and enjoy being part of a highly visible team Ability to collaborate and communicate with all levels of the organization Continuous improvement mindset with a passion for Quality Degree(s) in Science or Engineering 5+ years of experience in Quality Systems Training/certifications in Quality Management System Requirements (ISO 13485) and FDA Quality Management System Regulation Hands-on Project Management experience Requisition ID: 635647 Minimum Salary: $ 85000 Maximum Salary: $ 161500 The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com— will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above. Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements). Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements). For MA positions : It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability. Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class. Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law. Nearest Major Market: Minneapolis Job Segment: Compliance, Senior Quality Engineer, Medical Device Engineer, Quality Engineer, Systems Engineer, Legal, Engineering Apply now » Apply Now Start apply with LinkedIn Please wait... Find similar jobs: Quality Jobs in Maple Grove, MN, Quality, All Jobs in Quincy, MA, All Jobs in Natick, MA, All Jobs in Marlborough, MA Careers Home Top Jobs Searches View All Jobs Privacy Policy Terms of Use Copyright Notice Contact Us Corporate Home ©2017 Boston Scientific or its affiliates. All rights reserved. Cookie Consent Manager When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. Because we respect your right to privacy, you can choose not to allow some types of cookies. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer. Required Cookies These cookies are required to use this website and can't be turned off. 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