Quality Manager - Medical Device

Overview 3–6 Month Contract, Full-Time (40 hrs/week) with potential to convert to permanent Relocation Assistance is available for the right candidate. We are seeking an experienced Quality Manager– Medical Device to support a growing medical device company specializing in emergency medical technologies. This role will be a critical member of the cross-functional team, ensuring compliance with FDA, ISO, and Quality System requirements while driving operational excellence and continuous improvement. Key Responsibilities Act as the voice of Quality within operations, ensuring compliance with regulatory standards. Lead and support CAPA, Complaints, Non-Conformances, and Audit activities . Conduct risk management, root cause analysis, and process validations . Partner with manufacturing, suppliers, and warehouse teams to improve processes and maintain quality standards. Support supplier quality, incoming inspections, and change management processes . Participate in internal, external, and supplier audits . Apply statistical methods (SPC, sampling plans, Gage R&R, Minitab) for data-driven decision making. Mentor and guide team members to strengthen the culture of quality. Qualifications 5+ years of medical device quality engineering experience (required). Strong background in CAPA, Complaints, Non-Conformances, and Audits . Bachelor’s degree in Engineering, Quality, Biomedical, or related STEM field . Experience with risk management, process validation, and supplier quality . Excellent communication and collaboration skills to partner with cross-functional teams. Preferred: Experience with kitting (Medline, BoundTree, or similar companies) . Preferred: Experience with sterilization, packaging validation, and 3D modeling/drafting . Proficiency in Minitab or other statistical analysis tools. Location & Type Location: Charlotte, NC Employment type: Full-time Note: Relocation assistance available for the right candidate. #J-18808-Ljbffr