Quality System Specialist

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

Now Hiring: Quality Systems Specialist (Medical Devices)

Client Industry: Orthopedic Medical Devices & Musculoskeletal Healthcare

Contract Duration - 10 months/W2

We are hiring a Quality Systems Specialist to support a leading global organization in the orthopedic medical device sector. This role focuses on ensuring compliance, harmonization, and continuous improvement of the Quality Management System (QMS) in alignment with global medical device regulations.

Key Responsibilities

• Support global development, implementation, and continuous improvement of the Quality Management System (QMS).
• Conduct gap assessments of local procedures against corporate policies and global medical device regulations.
• Partner cross-functionally with R&D and Regulatory teams to update and align quality procedures.
• Drive harmonization and standardization of quality processes across sites and regions.
• Ensure compliance with applicable regulatory standards and internal requirements.

Required Experience & Skills

• 5+ years of experience in Quality or Regulatory Compliance within the medical device industry.
• Strong knowledge of:
• FDA 21 CFR Part 820
• ISO 13485
• EU MDR
• ISO 14971
• Hands-on experience with QMS elements including:
• Design Controls
• CAPA
• Nonconformance Management
• Purchasing Controls
• Validation
• Familiarity with quality tools such as Six Sigma, FMEA, SPC, and root cause analysis.
• Experience with enterprise systems such as SAP and EtQ Reliance preferred.
• Experience with Software as a Medical Device (SaMD) and Class II devices is a plus.
• Bachelor’s degree in Engineering or related technical field preferred.