MedTech Quality Supervisor – ISO 13485 & FDA Compliance

Graham Personnel Services; High Point (NC); On-site; USD 55,000 - 60,000; Full time

Job summary

Graham Personnel Services is seeking a Quality Supervisor to uphold medical device quality standards and regulatory compliance. You will support QMS implementation, supervise inspectors, and drive CAPA projects across operations and engineering.

Qualifications include 2+ years in quality leadership, knowledge of GMP, ISO 13485, and FDA 21 CFR Part 820, with strong cross‑functional collaboration and problem solving.

Qualifications

• 2+ years of quality management or supervisory experience.
• Knowledge of GMP, FDA 21 CFR Part 820, ISO 13485 and applicable quality standards.
• Experience with Quality Management Systems (QMS) and audits or CAPA processes.

Responsibilities

• Assist Quality Manager in establishing and maintaining QMS per regulatory requirements and ISO 13485.
• Develop and implement quality policies, procedures, work instructions, and documentation.
• Ensure processes and finished products meet quality standards and regulatory requirements.
• Drive continuous improvement by defining metrics, analyzing data, and recommending CAPA actions.
• Collaborate across departments to identify and mitigate quality risks in manufacturing and distribution.
• Supervise Quality Inspectors and the Quality Coordinator; oversee Supplier Quality workflows.

Skills

Quality mgmt

Supervisory

GMP

FDA 21 CFR 820

ISO 13485

QMS

Audits

CAPA

Leadership

Cross-functional

Regulatory awareness

Education

Bachelor’s/Associate in Quality/Eng/Manufacturing/Life Sciences

Tools

QMS software

Job description

Graham Personnel Services is seeking a Quality Supervisor to uphold medical device quality standards and regulatory compliance. You will support QMS implementation, supervise inspectors, and drive CAPA projects across operations and engineering.

Qualifications include 2+ years in quality leadership, knowledge of GMP, ISO 13485, and FDA 21 CFR Part 820, with strong cross‑functional collaboration and problem solving.