Quality Assurance Engineer

2 weeks ago


Cambridge, Massachusetts, United States Roche and Genentech Full time
Job Overview

The Quality Assurance Engineer plays a crucial role within the Quality Systems division at Roche and Genentech, collaborating with diverse teams throughout the organization. This position is essential in ensuring that the Quality Management System, Corrective and Preventive Actions (CAPA), and Non-conformance processes are not only effective but also compliant with industry standards.

Key Responsibilities:

  • Quality Management Support: Assist in the implementation of continuous improvement initiatives and standardization of the quality system across all departments.
  • Cross-Functional Collaboration: Work effectively with various teams to facilitate the successful completion of quality-related projects.
  • Quality Management Systems Maintenance: Oversee the Quality Management Systems relevant to your functional area, including Design Controls, Software Development, Risk Management, and CAPA systems.
  • Root Cause Analysis: Support the identification of root causes and the implementation of corrective and preventive actions, ensuring the effectiveness of these actions is verified as required.
  • Performance Monitoring: Develop, measure, and monitor key performance indicators to assess quality objectives.
  • Other responsibilities as assigned.

Preferred Qualifications:

  • Degree in a Science, Engineering, or Business-related field.
  • Experience with IVD or Medical Device Quality Systems.
  • Familiarity with standards and regulations relevant to the IVD and/or Medical Device industry, including FDA QSR 820, ISO 13485, ISO 15189, CAP/CLIA, and IVD/IVDR.
  • Understanding of CAPA and Root Cause Investigations.
  • Knowledge of Good Manufacturing Practices.
  • Strong communication skills and the ability to influence effectively regarding quality system processes.
  • Ability to thrive in a fast-paced environment with meticulous attention to detail.
  • Proficiency in Microsoft Office Suite, including Word, Excel, Project, and PowerPoint.
  • Effective teamwork skills within a multidisciplinary environment.
  • Understanding of HIPAA and the importance of patient data privacy.
  • Commitment to the core values of Roche and Genentech: patient focus, innovation, collaboration, and passion.

Basic Qualifications:

  • Bachelor's Degree; OR
  • 5+ years of equivalent related experience.

This position offers a competitive pay range and benefits including Medical, Dental, Vision, and 401K, subject to meeting minimum eligibility hours.

Roche and Genentech are committed to fostering diversity and inclusion within our workforce. We believe that embracing diverse perspectives leads to innovation and better business outcomes.



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