Quality Assurance Engineer

Posted 10 Days Ago
Indianapolis, IN, USA
In-Office
Mid level
Professional Services • Biotech • Consulting • Pharmaceutical
The Role
Provides quality assurance support for engineering activities in a regulated biomedical product environment. Reviews and approves controlled documents and quality records, supports changes, deviations, risk assessments, and design and development activities, and maintains documentation in the Dot Compliance eQMS. The role also escalates quality concerns, ensures QMS compliance, and contributes to continuous improvement initiatives.
Summary Generated by Built In
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 LLC website.

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.

Skills Required

  • 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.
  • 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 escalate concerns appropriately.
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The Company
63 Employees
Year Founded: 2015

What We Do

Adjutant Solutions Group is a global engineering and business process management consultancy specializing in regulated industries, particularly the pharmaceutical and medical device sectors. They partner with clients to orchestrate complex projects, focusing on the development, qualification, and commercialization of drug delivery systems and medical devices to help them reach the market faster and more efficiently.

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