Quality Engineer is needed for a leading manufacturer in the medical device industry based in Austell, GA. The ideal candidate will bring experience in ISO 13485, ISO 14971, design control, validations, and quality systems, with a preference for experience in EU MDR technical documentation.
This is a permanent job opportunity with benefits options available.
APPLY NOW!
location: Austell, Georgia
job type: Permanent
salary: $90,000 - 100,000 per year
work hours: 8am to 4pm
education: Bachelors
responsibilities:
- 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, ISO 14971
- Experience with EU MDR technical documentation
qualifications:
- Experience level: Experienced
- Minimum 5 years of experience
- Education: Bachelors (required)
skills:
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
