Quality Manager – Medical Device

Confidential; Charlotte (NC); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

A leading medical device organization seeks a Quality Manager in Charlotte, NC, to ensure compliance with FDA and ISO standards. This full-time role involves leading quality activities and mentoring team members. Ideal candidates have over 5 years in quality engineering and a relevant degree. Relocation assistance is available.

Qualifications

• 5+ years of medical device quality engineering experience.
• Strong background in CAPA, Complaints, Non-Conformances, and Audits.
• Preferred experience with kitting and sterilization.
• Excellent communication and collaboration skills.
• Preferred: experience with kitting (Medline, BoundTree, or similar).
• Preferred: experience with sterilization, packaging validation, and 3D modeling/drafting.
• Proficiency in Minitab or other statistical analysis tools.

Responsibilities

• Ensure compliance with FDA, ISO, and Quality System requirements.
• Lead 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.
• 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 decisions.
• Mentor and guide team members to strengthen the culture of quality.

Skills

Medical device quality engineering

CAPA

Compliance with regulatory standards

Communication

Collaboration

Education

Bachelor’s degree in Engineering, Quality, Biomedical, or related STEM field

Tools

Minitab

Job description

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.