Quality Engineer

Job Summary

Quality Engineer position at a leading medical device manufacturer in Austell, GA. The ideal candidate holds experience in ISO 13485, ISO 14971, design control, validations, and quality systems, with a preference for EU MDR technical documentation.

Permanent role with benefits options available.

Location:

Austell, Georgia
• Job Type: Permanent
• Salary: $90,000–$100,000 per year
•

Work Hours:

8 am to 4 pm
•

Education:

Bachelors.

• Own the creation, maintenance, and continuous improvement of Risk Management Files in accordance with ISO 14971.
• Facilitate cross‑functional risk assessments throughout the product lifecycle.
• Ensure compliance with ISO 13485, FDA QSR, and internal quality system requirements.
• Partner with R&D to ensure quality is built into the design and development of new products.
• Lead or support internal investigations, including CAPA and nonconformances.

• ​Bachelor's degree in engineering, life sciences, or related technical discipline.
• 5+ years of experience in quality engineering.
• Experience in manufacturing within the medical device industry.
• Knowledge of ISO 13485 and ISO 14971.

• Experience with EU MDR technical documentation.

• Quality Systems
• Medical Device
• Regulatory Affairs / Compliance
• Compliance
• QMS
• CAPA
• ISO 13485
• 21 CFR 820
• EU MDR
• Supply Chain
• ISO 9001
• Quality

Pay will be based on education, experience, location, and specific duties. Randstad offers a comprehensive benefits package, including medical, prescription, dental, vision, AD&D, life insurance, short‑term disability, and a 401(k) plan (eligibility applies).

Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.