Quality Systems Manager

Full Time Indirect New Hope, MN, US Quality Systems Manager About Lake Air Products Lake Air Products is a fast-growing contract manufacturer serving medical, aerospace & defense, industrial markets and more. We are committed to quality, performance, and building strong teams while proudly living by our Core Values: Customer Focus, Passion for Performance, and Right People – Best Teams. Position Summary The Quality Systems Manager is responsible for developing, implementing, maintaining, and continuously improving the organization's Quality Management System (QMS) to ensure compliance with customer, regulatory, and certification requirements. This role serves as the primary owner of quality system compliance, certification readiness, and audit activities, leading corrective action programs, documentation control, employee training, and continuous improvement initiatives. By partnering with cross-functional teams, the Quality Systems Manager identifies and closes compliance gaps, strengthens process effectiveness, mitigates risk, and fosters a culture of quality throughout the organization. Serves as the organization's subject matter expert for ISO 9001, ISO 13485, AS9100, customer-specific requirements, and quality system best practices, providing guidance and support to leadership and operational teams. Leads internal audit programs and coordinate external certification and surveillance audits. Owns corrective and preventive action (CAPA) processes and verify effectiveness of corrective actions. Conducts gap assessments against ISO 9001, ISO 13485, AS9100, customer-specific, and regulatory requirements. Manages document control processes and QMS documentation structure. Facilitates Management Review meetings and report QMS performance metrics. Leads risk-based thinking and risk management activities throughout the QMS. Drives certification readiness initiatives and ensure successful maintenance of quality certifications. Develops and implements quality training programs in partnership with departmental leaders to strengthen quality awareness and technical competency throughout the organization. Oversees quality system records and workflows, including corrective actions, nonconformance records, customer complaints, and change management activities, ensuring timely review, resolution, and compliance with QMS requirements. Establishes and maintains quality management system objectives and key performance indicators that align with corporate goals, customer requirements, and continuous improvement initiatives. Qualifications Minimum of 10 years of progressive quality management experience within a manufacturing environment. Minimum of 3 years of experience in a custom metals fabrication or contract manufacturing environment preferred. Demonstrated ability to lead, develop, and manage a team of quality professionals to achieve departmental and organizational objectives. Strong ability to analyze and interpret quality metrics, operational data, financial reports, and departmental budgets to drive informed business decisions. Bachelor's degree from an accredited college or university in Engineering, Quality, Manufacturing, or a related field; equivalent combinations of education and relevant experience will be considered. PREFERRED CERTIFICATES, LICENSES, and REGISTRATIONS EXPERIENCE ASQ Certification ISO 9001 Certification Project Management Lean/Six Sigma NADCAP Lake Air Products Offers: Competitive Pay Full Benefits 401(k) Employer Match Paid Time Off (PTO) and Holiday Pay Tuition Reimbursement Please note that this position may require travel to our Roseville, MN facility and may be subject to export control regulations. Unless an exemption applies, candidate(s) must be a U.S. Person* within the meaning of the law or obtain an export control license. Candidates who do not meet the International Traffic in Arms Regulations (ITAR) requirements or choose not to pursue such positions are not disqualified from applying for other opportunities with Lake Air Products. Nothing in this posting should be interpreted as limiting applications based on nationality or citizenship status. *A U.S. Person under export control laws includes a U.S. citizen, U.S. national, U.S. permanent resident, or protected individual who has been lawfully admitted for temporary residence in the U.S. as a refugee or asylee under U.S. law. Join a company where your hard work, dedication, and growth matter. We look forward to meeting you! #J-18808-Ljbffr