Design Quality Assurance Engineer Job

Design Quality Assurance Engineer is needed to perform the following duties:

· Provide quality and regulatory compliance input across project deliverables, including Design Change Analysis, Design Inputs/Outputs, Test Methods, Design Reviews, Design Verification & Validation (V&V), Usability Testing, Process Validation, and Labeling.

· Specifically, this includes:

- Updating Trace matrix with the help of requirements.

- Participate and provide input to project meetings.

- Linking Design Inputs with Design outputs

· Support risk management activities by developing plans and maintaining product risk documentation in accordance with applicable regulatory standards.

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· Specifically, this includes:

· - Updates to Risk Management Plan, Medical Device Hazard Analysis, Design/Process/User Failure Mode Effective Analysis, Benefit Risk Analysis and Risk Management Report

· Contribute to usability engineering processes, including planning and supporting associated documentation

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· Specifically, this includes:

· Creation of Usability documents that includes Use Specification, Usability Engineering report, Summative evaluation, User interface specifications

· Implement and monitor effective quality assurance processes, leveraging statistical analysis and performance metrics

· Specifically, this includes:

· The sample size selection based on risk that is being imposed and statistical tools to analyze the test results.

· Analyze and present quality trending data to generate actionable insights and drive continuous improvement

· Specifically, this includes:

· - Updating the design of the devices based on the post market surveillance data

· Support post-market activities, including design changes, supplier audits, and complaint investigations

· Specifically, this includes:

· -Maintaining Design of the devices based on the PMS data

· Lead post-market surveillance efforts, including product performance monitoring, customer feedback analysis, and CAPA (Corrective and Preventive Actions) initiatives

· Specifically, this includes:

- Doing Investigations and crating action plans to reduce the Failure from happening by reducing the occurrence of the Failure mode

· Proactively identify, prioritize, communicate, and resolve quality issues to ensure product compliance and performance

· Specifically, this includes:

- Maintaining device compliance with external standards by resolving the quality issues by updating design history file documents