Quality Engineer

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

Job Description

Quality Engineer

Location: Kennesaw, Ga

Schedule: Monday - Friday, 8am- 5pm

TRC Talent Solutions is seeking a Quality Engineer to support quality activities throughout the product lifecycle, including new product development, validation, commercialization, and sustaining engineering. This role partners with cross-functional teams to ensure products and processes meet quality, regulatory, and customer requirements.

Key Responsibilities

• Support process validation activities, including PFMEA, IQ, OQ, and PQ.
• Develop and execute verification and validation protocols and reports.
• Ensure compliance with FDA regulations, ISO 13485, and other applicable standards.
• Participate in risk management activities, including ISO 14971 and Design FMEA.
• Investigate quality issues, customer complaints, and support root cause analysis.
• Review product designs for quality, reliability, and manufacturability.
• Support supplier quality and continuous improvement initiatives.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field; equivalent experience considered.
• 2+ years of quality engineering experience, preferably in the medical device industry.
• Experience with process validation, risk management, statistical analysis, and quality systems.
• Familiarity with Minitab, Lean Manufacturing, and Six Sigma methodologies preferred.
• Strong communication, technical writing, and project management skills.

Physical Requirements

• Ability to sit, stand, walk, and occasionally lift up to 50 lbs.
• Reasonable accommodations may be made for qualified individuals with disabilities.

TRC Talent Solutions is proud to be an Equal Opportunity Employer (EOE). All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, protected veteran status, disability status, sexual orientation, gender identity or expression, marital status, genetic information, or any other characteristic protected by law. At TRC, we take pride in fulfilling our opportunity to add value to our client's business as their staffing partner, while working tirelessly to connect thousands of individuals each year with work opportunities where they can meet the needs of their families and have the potential to build their careers.