Quality Engineer II: Validation & Compliance Leader

StimLabs; Roswell (GA); On-site; USD 90,000 - 130,000; Full time

Job summary

StimLabs is seeking a Quality Engineer II to provide technical expertise and lead quality initiatives in tissue banking and medical device manufacturing. You will drive validations, risk assessments, and continuous improvement across manufacturing processes and product lifecycles.

The role requires strong knowledge of FDA, AATB, and ISO 13485 standards, plus hands-on experience with environmental monitoring, CAPA, and change controls.

Qualifications

• Minimum bachelor's degree in a technical field with at least five years in QA and validation in FDA-regulated facilities.
• Strong knowledge of regulatory requirements (21 CFR 1271, ISO 13485, cGMP, FDA Part 11).
• Experience in software validations and equipment qualifications.
• Ability to support regulatory teams in writing, validating, and testing requirements.
• Experience with environmental monitoring and CAPA investigations.

Responsibilities

• Lead software/process validations and equipment qualifications.
• Review data from validations and qualifications.
• Support calibration and maintenance programs for equipment and facilities.
• Assist commissioning new equipment and decommissioning.
• Assist change controls and validation reassessments.
• Own environmental continuous monitoring system.
• Lead third-party execution for Cleanroom recertification.
• Develop and revise quality system procedures and work instructions.
• Investigate deviations and CAPA per SOPs.
• Support product development to production transfers with quality tools.

Skills

Quality Assurance

Validation

Data analysis

Process improvement

Risk management

Statistical analysis

Regulatory knowledge

Project management

Education

Bachelor's degree in a technical field

Tools

eQMS

CAPA software

Statistical software

Job description

StimLabs is seeking a Quality Engineer II to provide technical expertise and lead quality initiatives in tissue banking and medical device manufacturing. You will drive validations, risk assessments, and continuous improvement across manufacturing processes and product lifecycles.

The role requires strong knowledge of FDA, AATB, and ISO 13485 standards, plus hands-on experience with environmental monitoring, CAPA, and change controls.