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.

• 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.

• 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, Bound Tree, or similar companies).
• Preferred:
  
  Experience with
  sterilization, packaging validation, and 3D modeling/drafting
  .
• Proficiency in Minitab or other statistical analysis tools.

Location:

Charlotte, NC

Employment type:

Full-time

Note:

Relocation assistance available for the right candidate.