Quality Engineer

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

The Quality Engineer II provides technical expertise and quality support for manufacturing process improvements and product lifecycle activities within the tissue banking and medical device industry. This position independently leads quality projects requiring validation or equipment qualification, ensuring compliance with FDA, AATB, and ISO 13485 regulations, and drives continuous improvement initiatives. The Quality Engineer II applies risk management, data analysis, and validation principles to enhance product quality, process robustness, and system effectiveness.

KEY RESPONSIBILITIES

• Leads and performs software/process validations and equipment qualifications with guidance/support from Quality Engineering Management.
• Performs Quality review of data generated from software/process validations and equipment qualifications.
• Supports calibration and corrective/preventative maintenance programs for production equipment, test equipment, analytical equipment, and the facility within the eQMS.
• Support commissioning new equipment and decommissioning existing equipment inclusive of tag out activities required per procedure.
• Supports the change control system through performance of Validation assessments.
• Performs Validation reassessments and requalifies critical equipment based on established frequencies.
• Own and facilitate the execution and maintenance of environmental continuous monitoring system.
• Lead and document 3rd party execution for Cleanroom recertification activities.
• Develop or revise Quality System procedures, Standard Operation procedures, Work Instructions and Forms.
• Perform and document investigations for deviations and CAPA as applicable in a timely manner in accordance with Quality System procedures.
• Leads or participates in corporate or quality projects for continuous improvement and to identify potential quality issues.
• Supports product development and operations departments to ensure successful transition of products and processes from design to production by applying quality tools and methods.
• Perform statistical analysis and design experiments to support processing development, process control, and process improvement.
• Collect, analyze, and prepare key performance report data to management as applicable.
• Supports risk management activities in accordance with ISO 14971 and design control requirements.
• Support internal and external audits (FDA, ISO, AATB) and ensure compliance with quality and regulatory standards.

REQUIRED QUALIFICATIONS

• Bachelor's degree in a technical/relevant field, with at least five (5) years of Quality Assurance and related Validation experience in a pharmaceutical, medical device, biologic, or tissue banking FDA regulated facility; or an appropriate combination of education, certification and work experience
• Knowledge and understanding of regulatory requirements, including but not limited to 21 CFR 1271, AATB, ISO 13485, cGTP, cGMP, 21 CFR 820, 21 CFR 210 & 211, and other applicable state and federal regulations.
• Knowledge of IEC 62304 (FDA Software Validation), FDA quality systems regulation, and FDA 21 CFR part 11.
• Ability to support the regulatory team in writing, validating, and testing requirements.
• Experience with analytical and software validations and qualifications.
• Ability to represent Quality and Regulatory on multiple concurrent projects.
• Ability to identify Quality Management System (QMS) needs.
• Ability to support production and the production team.

PREFERRED QUALIFICATIONS

• Greenbelt (or higher) in Lean Six Sigma