Quality Systems Specialist — Medical Devices (10-mo Contract)

Swoon; Austin (TX); On-site; USD 80,000 - 100,000; Full time

Job summary

A healthcare staffing agency is seeking a Quality Systems Specialist in Austin, Texas, to enhance the Quality Management System (QMS) for a leading orthopedic medical device company. Responsibilities include supporting QMS development, conducting compliance assessments, and partnering with various teams to ensure quality processes are standardized. Candidates should have 5+ years in quality/regulatory compliance, a strong understanding of industry regulations, and relevant technical skills. A Bachelor’s degree in Engineering or a related field is preferred.

Qualifications

• 5+ years of experience in Quality or Regulatory Compliance within the medical device industry.
• Hands-on experience with QMS elements including Design Controls, CAPA, and Nonconformance Management.
• Experience with Software as a Medical Device (SaMD) and Class II devices is a plus.

Responsibilities

• Support global development and continuous improvement of the Quality Management System (QMS).
• Conduct gap assessments against corporate policies and regulations.
• Partner with R&D and Regulatory teams to align quality procedures.

Skills

Quality Compliance

FDA 21 CFR Part 820

ISO 13485

EU MDR

ISO 14971

Six Sigma

FMEA

SPC

Root Cause Analysis

Design Controls

CAPA

Nonconformance Management

Purchasing Controls

Validation

SAP

EtQ Reliance

Software as a Medical Device (SaMD)

Education

Bachelor’s degree in Engineering or related technical field

Job description

A healthcare staffing agency is seeking a Quality Systems Specialist in Austin, Texas, to enhance the Quality Management System (QMS) for a leading orthopedic medical device company. Responsibilities include supporting QMS development, conducting compliance assessments, and partnering with various teams to ensure quality processes are standardized. Candidates should have 5+ years in quality/regulatory compliance, a strong understanding of industry regulations, and relevant technical skills. A Bachelor’s degree in Engineering or a related field is preferred.