QA Engineer - Regulated Biotech | QMS & Documentation

The Solutions Group Llc; Indianapolis (IN); On-site; USD 65,000 - 90,000; Full time

Job summary

Adjutant Solutions Group (ASG) is seeking a QA Engineer to support engineering activities and ensure compliance with the QMS and industry standards. The role involves reviewing documents, maintaining quality records, and promoting continuous improvement within ASG’s engineering teams.

You will collaborate with the Quality Risk Manager to address deviations, perform risk assessments, and escalate issues as needed. Experience with Salesforce or eQMS platforms is preferred.

Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, or a related technical field; equivalent experience may be considered.
• 2 to 5 years of experience in Quality Assurance, Quality Engineering, Engineering, or a regulated technical environment.

Responsibilities

• Review and approve Engineering controlled documents and quality records.
• Ensure compliance with ASG QMS requirements and Engineering Quality practices.
• Provide QA support for changes, deviations/nonconformances, risk assessments, and Design & Development activities.
• Document QA reviews, approvals, comments, and escalations within the Dot Compliance eQMS.
• Escalate significant quality, compliance, or risk concerns to the Quality & Regulatory Manager (QRM).
• Support continuous improvement initiatives related to Engineering processes and the QMS.
• Familiarity with Salesforce, Dot Compliance eQMS, or similar quality management systems.

Skills

Quality Assurance

Document control

Traceability

Analytical thinking

Technical writing

Communication

Education

Bachelor's degree in Engineering/Quality/Life Sciences

Tools

Salesforce

Dot Compliance eQMS

Job description

Adjutant Solutions Group (ASG) is seeking a QA Engineer to support engineering activities and ensure compliance with the QMS and industry standards. The role involves reviewing documents, maintaining quality records, and promoting continuous improvement within ASG’s engineering teams.

You will collaborate with the Quality Risk Manager to address deviations, perform risk assessments, and escalate issues as needed. Experience with Salesforce or eQMS platforms is preferred.