Manufacturing Quality & TestValidation, Compliance & Quality Systems
About the job
Requirements
A bachelor's degree in Engineering, Quality, Life Sciences, or a related technical field; equivalent experience may be considered.
Two to five years of experience in Quality Assurance, Quality Engineering, Engineering, or a regulated technical environment.
Working knowledge of Quality Assurance principles in a regulated environment.
Experience with document control, review, approval, and traceability requirements.
Strong analytical, problem-solving, technical writing, and organizational skills.
Effective verbal and written communication skills.
Ability to independently review Engineering documentation, make quality decisions within defined authority, and appropriately escalate concerns.
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.
Desired Qualifications
Familiarity with Salesforce, Dot Compliance eQMS, or similar quality management systems.
Adjutant Solution Group (ASG) ASG specializes in the development, qualification, and commercialization of drug delivery systems for biomedical products. We deliver integrated business and science solutions to foster healthier, safer, and more prosperous communities. Guided by our core values—service, client success, curiosity, respect, integrity, and accountability—we value diversity and prioritize collaboration and growth within our inclusive, team-oriented culture. Check out our Adjutant Solutions Group - Adjutant Solutions Group LLCwebsite.
QA Engineer Role Summary The Quality Assurance Engineer provides Quality Assurance support for Engineering activities to ensure compliance with ASG's Quality Management System (QMS), regulatory requirements, and industry standards. This role is responsible for reviewing and approving engineering documentation, supporting quality processes, maintaining records within Dot Compliance eQMS, and promoting continuous improvement initiatives. The QA Engineer works closely with Engineering teams and the Quality Risk Manager (QRM) to support quality and compliance objectives.
Key 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.
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.
Knowledge, Skills & Abilities
Working knowledge of Quality Assurance principles in a regulated environment.
Experience with document control, review, approval, and traceability requirements.
Familiarity with Salesforce Dot Compliance or similar eQMS platforms.
Strong analytical, problem-solving, technical writing, and organizational skills.
Effective verbal and written communication skills.
Ability to independently review Engineering documentation, make quality decisions within defined authority, and appropriately escalate concerns.
Core Values: Behaviors
Accountability: Owning the consequences of your decisions and actions.
Integrity: Complete harmony in what you think, say, and do concerning the ASG Way and our Code of Conduct.
Respect: Treating people how you want to be treated, whether or not you agree with them.
Curiosity: An enduring desire to learn and grow.
Client Service: Results that address client needs based on client decisions.
Service: Giving priority to enriching the lives of others.