Medical Device Quality Engineer - Validation & Compliance

TRC Talent Solutions; Georgia; On-site; USD 70,000 - 90,000; Full time

Job summary

TRC Talent Solutions seeks a Quality Engineer to support quality activities across the product lifecycle—development, validation, and sustaining engineering—collaborating with cross‑functional teams to ensure quality and regulatory compliance.

The role emphasizes process validation, risk management, and continuous improvement, with exposure to FDA regulations and ISO 13485, and collaboration with suppliers to uphold quality standards.

Qualifications

• Bachelor's degree required in Engineering, Life Sciences, or related field.
• 2+ years of quality engineering experience (medical device preferred).
• Experience with process validation, risk management, statistics, and quality systems.
• Familiarity with Minitab, Lean Manufacturing, and Six Sigma is a plus.
• Strong written and verbal communication skills.

Responsibilities

• Support process validation activities (PFMEA, IQ/OQ/PQ).
• Develop and execute verifications and validation reports.
• Ensure compliance with FDA, ISO 13485 and other standards.
• Participate in risk management (ISO 14971, FMEA).
• Investigate quality issues and support root cause analysis.
• Review designs for quality, reliability, and manufacturability.
• Support supplier quality and continuous improvement.

Skills

Quality engineering

Communication

Technical writing

Project management

Process validation

Risk management

Statistical analysis

Quality systems

Education

Bachelor's degree in Engineering, Life Sciences, or related field

Tools

Minitab

Lean manufacturing

Six Sigma

Job description

TRC Talent Solutions seeks a Quality Engineer to support quality activities across the product lifecycle—development, validation, and sustaining engineering—collaborating with cross‑functional teams to ensure quality and regulatory compliance.

The role emphasizes process validation, risk management, and continuous improvement, with exposure to FDA regulations and ISO 13485, and collaboration with suppliers to uphold quality standards.