Quality Engineer
Prophecy Technologies
- Support Design History File (DHF) activities for medical device development projects.
- Review, update, and maintain Global dFMEA documentation ensuring risks are adequately identified, analyzed, and mitigated.
- Review, update, and maintain Global uFMEA documentation based on product use scenarios and user-related risks.
- Develop and update Preliminary Hazard Analysis (PHA) documentation in accordance with risk management procedures.
- Support creation and maintenance of product risk management files throughout the development lifecycle.
- Prepare, review, and update Product Characterization documents to define product performance and design intent.
- Create and maintain Product Specification Documents (PSD) ensuring alignment with design requirements and customer needs.
- Develop and update Critical-to-Quality (CTQ) documents and establish measurable quality requirements.
- Support development and maintenance of Design Input, Design Output, Verification, and Validation documentation.
- Ensure traceability between user needs, design inputs, risk controls, verification activities, and design outputs.
- Collaborate with Design, Quality, Regulatory, Manufacturing, and Project Management teams to support product development deliverables.
- Participate in design reviews and provide technical input on risk management and DHF compliance.
- Support engineering change assessments and associated documentation updates.
- Review engineering documents for completeness, accuracy, and compliance with quality system requirements.
- Identify gaps in documentation and recommend corrective actions.
- Support audits, inspections, and compliance activities related to design control and risk management documentation.
- Contribute to continuous improvement initiatives for product development and design control processes.
- Ensure all deliverables comply with applicable regulatory, quality, and Zimmer Biomet procedures and standards.
- Ability to establish document traceability between User Needs, Design Inputs, Design Outputs, Risk Management, Verification, and Validation records within Cockpit Cognition.
- Experience supporting DHF gap assessments, document linking, metadata management, and compliance reviews.
- Familiarity with digital DHF structure, document hierarchy, and traceability matrix development.
- Knowledge of DHF remediation projects and legacy design documentation migration into Cockpit Cognition.
- Communicate (written and verbal) direction and project plans with appropriate personnel from other departments.
Vacancy posted 23 hours ago
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