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.
• Assist 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

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.
• Applied statistical analysis experience.
• Excellent cross-functional collaboration and documentation skills.
• Familiarity with JAMA, Jira, Confluence, and Slack

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.
• Assist 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.
• Applied statistical analysis experience.
• Excellent cross-functional collaboration and documentation skills.
• Familiarity with JAMA, Jira, Confluence, and Slack.