Katalyst Healthcares and Life Sciences
Design Quality Engineer
Katalyst Healthcares and Life Sciences, San Francisco, California, United States, 94199
Responsibilities:
Design Verification Support:
Review and support design verification protocols and test reports. Ensure compliance with internal design verification, design control, equipment control, and risk management procedures. ssist cross-functional teams to complete design verification activities on time. Guide and support issue management, including opening, processing, and closure per internal processes. Support review and release of internal software tool validations. Quality Systems Support:
Handle ad-hoc quality needs as they arise. Ensure compliance with Good Documentation Practice (GDP). Review investigations, corrections, and CAPA/non-conformance activities. Support design control deliverables and phase closure readiness. Risk Management:
Help prepare for internal risk management reviews during design verification. Support evaluations and updates of internal risk management documentation. Process Improvement:
Participate in process improvement initiatives within the team. Requirements:
Strong understanding of FDA regulations for design control and verification and risk management. Knowledge of ISO 14971 and IEC 62304. Experience with computerized system validations. pplied statistical analysis experience. Excellent cross-functional collaboration and documentation skills. Familiarity with JAMA, Jira, Confluence, and Slack.
Review and support design verification protocols and test reports. Ensure compliance with internal design verification, design control, equipment control, and risk management procedures. ssist cross-functional teams to complete design verification activities on time. Guide and support issue management, including opening, processing, and closure per internal processes. Support review and release of internal software tool validations. Quality Systems Support:
Handle ad-hoc quality needs as they arise. Ensure compliance with Good Documentation Practice (GDP). Review investigations, corrections, and CAPA/non-conformance activities. Support design control deliverables and phase closure readiness. Risk Management:
Help prepare for internal risk management reviews during design verification. Support evaluations and updates of internal risk management documentation. Process Improvement:
Participate in process improvement initiatives within the team. Requirements:
Strong understanding of FDA regulations for design control and verification and risk management. Knowledge of ISO 14971 and IEC 62304. Experience with computerized system validations. pplied statistical analysis experience. Excellent cross-functional collaboration and documentation skills. Familiarity with JAMA, Jira, Confluence, and Slack.