Quality Lead

Title : Quality Lead Location : St. Paul, MN Job Type : Permanent Compensation : $30-35/hr Industry : Medical Supplies About The Role Our firm is partnering with an established, regulated manufacturing organization in the medical device and life sciences space that supports high-quality, mission-critical products used in healthcare applications. We are seeking a Quality Lead to serve as the owner and champion of the organization’s Quality Management System (QMS). This is a highly visible, hands‑on leadership role responsible for ensuring compliance with applicable standards, supporting audit readiness, and fostering a culture of continuous improvement and quality excellence across the organization. Job Description The Quality Lead is responsible for the development, implementation, maintenance, and continuous improvement of the Quality Management System (QMS). This individual acts as the subject matter expert for quality systems, audit readiness, documentation control, training, nonconformance management, and cross‑functional quality initiatives. The role balances strategic oversight with day‑to‑day execution, partnering closely with leadership and operations to ensure compliance with ISO standards, customer requirements, and applicable regulatory frameworks. Key Responsibilities Quality Management System (QMS) Oversight Own and maintain the QMS to ensure compliance with ISO and applicable regulatory requirements. Evaluate system effectiveness and implement improvements to drive scalability, efficiency, and compliance. Create, revise, and control QMS documentation including procedures, work instructions, and forms. Maintain strong document control practices and ensure record accuracy, traceability, and archival integrity. Cross-Functional Leadership & Representation Serve as the primary Quality representative across departments and in leadership discussions. Provide QMS guidance, clarification, and coaching to associates and leadership. Participate in tier meetings, leadership huddles, and cross‑functional initiatives to integrate quality into daily operations. Professionally communicate risks, opportunities, and compliance concerns with appropriate urgency and transparency. Training & Organizational Readiness Lead the QMS training program, including onboarding, refresher training, and ongoing awareness. Maintain training records and report gaps or overdue requirements to leadership. Nonconformance & Root Cause Management Lead investigations and resolution of NCRs, CARs, customer complaints, and other quality events. Facilitate root cause analysis (RCA) and oversee corrective and preventive actions (CAPAs). Ensure timely, compliant closure of CARs, DCNs, and complaint records. Supplier & Customer Quality Interface Manage customer complaints and coordinate investigations and responses. Interface with customers and suppliers during audits, inquiries, and escalations as required. Support supplier corrective action activities (SCARs) when applicable. Audit & Inspection Readiness Plan and conduct internal audits across departments. Serve as lead host and representative during customer, ISO, and regulatory audits. Conduct mock audits and gap analyses to maintain ongoing audit readiness. Performance Monitoring & Continuous Improvement Define and track quality KPIs, including NCRs, CARs, complaints, audit findings, and training compliance. Analyze data to identify trends and systemic improvement opportunities. Present reports and dashboards to leadership with actionable recommendations. Participate in the Material Review Board (MRB) and support nonconforming material disposition. Lead or support Lean, Six Sigma, and continuous improvement initiatives. Additional Responsibilities Escalate significant quality risks to leadership. Stay current on regulatory requirements and industry trends. Support departmental coverage and perform additional quality‑related duties as needed. Adhere to company health, safety, and cleanroom requirements. Qualifications Minimum 3 years of experience in a medical device, biotech, or other regulated manufacturing environment. Working knowledge of ISO 9001 and current Good Manufacturing Practices (cGMP). Minimum 3 years of experience supporting: Quality Management Systems (QMS) NCRs, CAPAs, ECOs, and document control Internal and external audits Proficiency in Microsoft Office (Word, Excel, Outlook). Strong written and verbal communication skills, including the ability to write procedures, reports, and respond to internal and external inquiries. Detail‑oriented, well‑organized, and able to prioritize work in a fast‑paced environment. Ability to work independently while collaborating effectively across departments. Professional demeanor aligned with organizational values and business objectives. Preferred Qualifications Bachelor’s degree or higher in a related field. Experience with electronic Quality Management Systems (eQMS) software. Experience with SharePoint workflows or collaboration tools. Training or experience in Lean, Six Sigma, or continuous improvement methodologies. Physical & Work Environment Requirements Ability to perform light physical work, including lifting up to 20 pounds. Regularly required to stand, walk, talk, hear, and use hands to handle tools, documentation, or inspection equipment. Occasional sitting, reaching, climbing, or balancing required. Ability to work in a manufacturing and cleanroom environment, including wearing required cleanroom garments (gowns, gloves, hair/beard coverings). Occasional exposure to production odors, moving mechanical parts, and moderate noise levels. Vision requirements include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus. Benefits We offer a competitive and comprehensive benefits package designed to support our associates’ health, financial security, and overall well‑being. Benefits include medical, dental, and vision coverage; employer‑paid basic life insurance, short‑term disability, and long‑term disability; supplemental voluntary life insurance; a Health Savings Account (HSA) with flexible spending options; a 401(k) with employer match; and generous paid time off. Additional benefits include nine paid holidays, continuing education and seminar opportunities, recognition and award programs, informational lunches, free tobacco cessation programs, an Employee Assistance Program (EAP), associate activities and wellness initiatives, and access to an on‑site fitness center. How To Apply Take the first step on your new career path! To submit yourself for consideration for this role, simply click the apply button and complete our mobile‑friendly online application. Once we’ve reviewed your application details, a recruiter will reach out to you with next steps! Equal Opportunity Statement As an equal opportunity employer, Dahl Consulting welcomes candidates of all backgrounds and experiences to apply. If this position sounds like the right opportunity for you, we encourage you to take the next step and connect with us. We look forward to meeting you! #J-18808-Ljbffr