Senior Quality Systems Engineer

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…