Quality Assurance Engineer for Medical Device Development

1 week ago

Indianapolis, Indiana, United States Adjutant Solutions Group Full time

We are seeking a highly skilled Quality Assurance Engineer to join our team at Adjutant Solutions Group. The ideal candidate will have experience in medical device development and a strong understanding of quality assurance principles.

About the Role

This role involves defining test sequences and methods to acquire objective product data, including performance, quality attributes, and cosmetic appearance. Key responsibilities include translating system requirements into formal test methods, recognizing and conforming to industry and client safety training, and designing and implementing customized test equipment and methodologies.

Responsibilities
  • Test Methodology Design: Develop characterized and formal test methods for verification purposes, ensuring compliance with product definition, company, and industry standards.
  • Safety Training and Compliance: Recognize and adhere to applicable industry and client safety training, procedures, and responses.
  • Testing Equipment and Methodologies: Design, develop, and implement customized test equipment, fixturing, methodologies, and instrumentation for product development testing.
  • Data Characterization: Perform standard device testing, such as DOE and GRR testing, to characterize and formalize methods.
  • Accuracy and Precision: Conduct test methods and protocols as written, recording results in real-time, in compliance with industry-standard practices.
  • Statistics and Standards: Apply working knowledge of basic statistics and identify and apply industry and client standards.
  • Technical Writing: Draft formal methods from requirements and design specifications for review and approval prior to test execution.
  • Preparation and Organization: Coordinate with engineers and verification execution resources to identify materials, material traceability, supply quantity, and availability, while tracking and maintaining test materials, requests, dates, issues, and deadlines.
  • Communication and Engagement: Report, display, present testing results and progress; communicate design or test issues and future improvements, contributing to technical team knowledge and capabilities of objective verification processes, standards, practices, and industry developments.
Requirements
  • Laboratory Knowledge: Mechanical device lab testing and lab equipment experience.
  • Expertise: Identify and articulate expected results of test steps, items, and cases for object demonstration of compliance to design and stakeholder needs.
  • Working Knowledge: Appropriate units of measure, measurement uncertainty, first-principles formulae.
  • Teamwork: Demonstrated proficiency in collaboration, challenge resolution, communication effectiveness, urgency negotiation, organization priorities, accountability, and work product integrity.
Salary

The estimated salary for this position is $85,000 - $115,000 per year, depending on qualifications and location.

About Us

Adjutant Solutions Group is a leader in development, qualification, and commercialization of drug delivery systems used for biomedical products. Our mission is to deliver integrated business and science solutions for healthier, safer, more prosperous communities. We value diversity and focus on growth and contribution through our core values: service, client success, curiosity, respect, integrity, and accountability.

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