ASSOCIATE QUALITY ENGINEER SKILLS, EXPERIENCE, AND JOB REQUIREMENTS

Updated: Aug 5, 2024 - The Associate Quality Engineer is tasked with interpreting technical drawings, schematics, and specifications to develop inspection methods and ensure adherence through detailed work instructions. This role involves analyzing failure trends, leading root cause investigations, and implementing corrective actions to uphold quality standards. Additionally, proficiency in Microsoft Office and a basic understanding of audit techniques are essential, alongside a capability to use causal analysis tools for resolving complex technical and process issues.

Summary of Associate Quality Engineer Knowledge and Qualifications on Resume

1. BS in Mechanical Engineering with 3 years of Experience

  • Demonstrate passion for enhancing quality in everything
  • Ability to test and validate scalable, extensible and high-performance healthcare suite of products.
  • Ability to create efficient Test cases for functional/component
  • Continuously improve, consolidate test scripts and product coverage.
  • Hands-on experience in MTM and TFS.
  • Hands-on experience in SDLC and STLC using Agile SAFe/SCRUM methods.
  • Support RCA exercises, propose corrective and preventive approaches for measurable improvements.
  • Willingness to configure, troubleshoot and deploy test environments.
  • Escalate concerns about project/product/process quality in clear, timely, collaborative and constructive way. 

2. BS in Electrical Engineering with 2 years of Experience

  • Experience performing root cause analaysis of technical discrepancies, abnormalities, and product non-conformances 
  • Experience preparing laboratory documentation (laboratory procedures, analysis spreadsheets, reference documents, and others)
  • Experience working in an FDA regulated environment 
  • Experience utilizing SAP for data trend analysis ideal.
  • Experience utilizing statiscal tools in Excel
  • Experience working in a lab environment utilizing microscopes
  • Ability to adapt to a variety of software applications required to perform investigations
  • Strong analystical and writing skills
  • Knowledge of Selenium automation, tools, web service/WebAPI testing using SOAPUI or Postman.

3. BS in Industrial Engineering with 4 years of Experience

  • Ability to communicate effectively with all levels of employees throughout the organization. 
  • Able to develop and maintain strong working relationships with internal and external customers.
  • Computer skills proficient in Microsoft Office, statistical software programs, operating systems, voice and email, etc.
  • Knowledge of quality systems and regulations for medical device industry
  • Knowledgeable with respect to quality systems, regulatory standards, supplier/subcontractor management, manufacturing systems, product development, project management, material flows, and general production principles. 
  • Responsible for supporting the implementation and administration of departmental procedures that will affect the long-term quality and manufacturing strategies within the organization.
  • Same mindset and commitment to be customer driven, focused on execution, and new product oriented.
  • Determined, optimistic team players.
  • Collaborative team player, quick learner, self-starter, independent owner and contributor.

4. BS in Software Engineering with 5 years of Experience

  • Ability to interpret drawings and specifications in order to develop inspection methods, and ensure proper testing via work instructions
  • Ability to review failure trends, lead investigations, assure that root causes are identified and corrective actions are implemented in a timely manner
  • Ability to interpret Drawings, Specifications, Contracts that will enable development and review of QE Processes, and related Performance Metrics
  • Ability to interpret electrical schematics, wiring diagrams, product / performance specifications and other systems integration technical data
  • Basic understanding of audit techniques, ability to travel
  • Ability to use causal analysis tools to analyze and resolve technical/process issues varying from basic to very complex
  • Knowledge of Configuration Management processes
  • Proficient skill level with Microsoft Office applications: Word, Excel, PowerPoint, etc.
  • Demonstrated presentation skills