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Senior Quality Assurance Analyst

2 months ago

Santa Clara, California, United States Planet Pharma Full time

Contract Position

Compensation: $38-$43 per hour

Position Overview:

The role involves contributing to the establishment and execution of a Quality Management System (QMS) along with the necessary tools and infrastructure to ensure compliance with FDA Quality System Regulation (QSR) and International Standards Organization (ISO) standards, as well as adhering to corporate guidelines. * Previous experience in Change Management, CAPA, and Non-conformance management is highly beneficial.* Familiarity with project-related documentation and Quality Management System (QMS) documentation using Electronic Document Management Systems (EDMS) is advantageous. Assist in the coordination of the document and record retention program to align with corporate requirements.

Key Responsibilities:

  • Review and document test scenarios.
  • Conduct and document risk assessments.
  • Track and report on testing progress and outcomes.
  • Evaluate test strategies.
  • Establish standards and procedures to assess product quality and readiness for release.
  • Promote innovation and enhance overall testing methodologies.
  • Identify potential user issues.
  • Investigate and analyze the features of the products under evaluation.
  • Explore new tools, technologies, and testing methodologies.
  • Examine user interfaces for consistency and functionality.

Required Qualifications:

  • 2-4 years of relevant experience in the medical diagnostics or device industry, including 1-2 years in Quality operations. Experience should focus on quality systems, regulatory compliance, or project management.
  • Familiarity with international ISO Standards (13485, 62304, 14971) and regulations (European medical/in-vitro devices directives, 21 CFR - part 820).
  • ASQ certifications such as Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), and/or Six Sigma Green Belt are advantageous.
  • Understanding of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) is essential.

Educational Background:

  • A Bachelor's degree in Biological Sciences, Engineering, or a related field, or an equivalent combination of education and professional experience.