Senior Biological Quality Assurance Specialist

2 weeks ago


Santa Clara, California, United States Joulé Full time

Position: Senior Biological Quality Assurance Specialist

Our client, Joulé, is seeking a qualified candidate to fulfill the role of Senior Biological Quality Assurance Specialist. The ideal applicant should possess a Bachelor's degree in Biological Sciences, Engineering, or a related discipline, or an equivalent combination of education and professional experience.

Qualifications:

  • 2-4 years of relevant experience in the medical diagnostic or device sector, with at least 1-2 years dedicated to Quality operations.
  • Experience in quality systems, regulatory compliance, or project management is essential.
  • Familiarity with international ISO Standards (13485, 62304, 14971) and regulations pertaining to medical and in-vitro devices, as well as 21 CFR - part 820.
  • Certifications such as ASQ Certified Quality Engineer (CQE), Auditor (CQA), and/or Six Sigma Green Belt are advantageous.
  • Comprehension of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) is required.

Key Responsibilities:

The successful candidate will be responsible for aiding in the development and execution of the Quality Management System (QMS) and associated tools to ensure compliance with FDA Quality System Regulation (QSR), International Standards Organization (ISO) standards, and corporate requirements.

Additional responsibilities include:

  • Managing change, Corrective and Preventive Actions (CAPA), and non-conformance issues.
  • Supporting project-related documentation and Quality Management System (QMS) documentation using Electronic Document Management Systems (EDMS).
  • Coordinating the document and record retention program in accordance with corporate standards.
  • Reviewing and documenting test cases and conducting risk analyses.
  • Tracking test progress and outcomes, as well as reviewing test plans.
  • Establishing standards and procedures to assess product quality and readiness for release.
  • Driving innovation and enhancing overall testing methodologies.
  • Identifying potential user issues and researching product features under evaluation.
  • Exploring new tools, technologies, and testing methodologies.
  • Ensuring user interfaces are consistent and functional.

Benefits:

Joulé offers eligible employees a comprehensive benefits package, which includes options for health and welfare coverage, such as medical, dental, and vision insurance, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.



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