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Quality Assurance Specialist III

Santa Clara, CA 95050

Posted: 08/05/2024 Employment Type: Contract Industry: Quality and Regulatory Affairs Job Number: 11817 Pay Rate: $38.00 - $43.00 Remote Friendly: Onsite

Job Description

Our client develops, manufactures and supplies a wide array of innovative medical diagnostic products, services, tests, platforms and technologies.

Overview:
  • Responsible for supporting development and implementation of Quality Management System (QMS) and supporting infrastructure/tools in compliance with FDA Quality System Regulation (QSR) regulations, International Standards Organization (ISO) regulations, and corporate requirements.
  • Experience in Change management, CAPA and Non-conformance management is an added advantage.
  • Good to have experience in supporting project-related and QMS documentation using Electronic Document Management System (EDMS). Support coordination of document and record retention program for the site in alignment with corporate requirements.

Duties:
  • Review and Document test cases
  • Perform and document risk analysis
  • Record test progress and results
  • Review test plans
  • Develop standards and procedures to determine product quality and release readiness
  • Drive innovation and streamline overall testing processes
  • Identify any potential problems that users might encounter
  • Research and analyze product features being tested
  • Research new tools, technologies, and testing processes
  • Review user interfaces for consistency and functionality

Job Requirements

Skills:
  • 2-4 years related experience in relevant medical diagnostic/device industry, including 1-2 years of direct Quality operations.
  • Experience focused on quality systems, regulatory affairs/compliance or project management.
  • Familiarity with relevant international ISO Standards (13485, 62304, 14971), and regulations (European medical/in-vitro devices directives, 21 CFR - part 820).
  • ASQ Certified Quality Engineer (CQE), Auditor (CQA) and/or Six Sigma Green Belt a plus.
  • Understanding of GMP and GLP requirements.

Education:
  • Bachelors' degree in Biological Sciences, Engineering or related field, or equivalent combination of education and work experience.

Meet Your Recruiter

Lexie Pierce
Recruiter

As a Compass recruiter, Lexie brings in 15 years of experience in leadership and employee growth and development. She's incredibly passionate about helping candidates find and accept new opportunities, ultimately leading her to start her recruiting career in the life science industry. Her favorite part about connecting with Compass candidates and clients is witnessing the excitement the candidates exude and making an impact on their lives.

 

Outside of the office, Lexie enjoys going to the farmers' market on Saturdays with her son so she can find the best produce to use in her family dinners. She enjoys cooking, reading, knitting, restoring furniture, and spending time with her family and friends. Lexie is also passionate about supporting organizations that are looking to educate the community about Congenital Heart Defects (CHD).

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About Santa Clara, CA

Ready to take the next step in your career? Explore our job opportunities in the vibrant area around Santa Clara, California. Located in the heart of Silicon Valley, this region offers unparalleled growth opportunities in tech, innovation, and beyond. With attractions like Levi's Stadium, the Santa Clara Convention Center, and the nearby California's Great America theme park, there's always something exciting to do. Indulge in the diverse culinary scene, catch a show at the Triton Museum of Art or the historic Santa Clara Theatre, or cheer for the San Francisco 49ers at Levi's Stadium. Discover why Santa Clara is the perfect place to elevate your career and enjoy a rich blend of culture and charm!