Consultant, Quality Engineer, Design History Files / Design Controls, Medical Devices

Summary

Our client, a rapidly growing medical device firm, has engaged GForce Life Sciences to provide a quality engineer to join their team and will be responsible for the design history file review effort by performing a full gap analysis of the design documentation of on-market legacy products.

Duties / Expectations of Role

• Responsible for collecting and assessing existing design documents, and to perform a gap analysis of the DHF / Design documentation based on current regulatory agencies' guidelines regarding design control.
• Responsible for drafting remediation protocols in order to complete and / or correct design documentation.
• Responsible for organizing an electronic repository and presenting it to appropriate Subject Matter Experts in order to assume a proper knowledge transfer.
• Assist with collection of existing design control documentation and establish an electronic repository for the organization of this documentation in compliance with applicable regulations governing the medical device industry, including but not limited to FDA regulations.
• Review design control activities for existing products including planning, risk assessment, design development, design verification and validation, design review, design change and documentation for design history file.
• Act as liaison with other departments to support design control review activities.
• Review (for accuracy and completeness) verification and validation data, including reports, spreadsheets, statistical summaries, for incorporation into project documentation.
• Perform a full assessment of on-market DHF / design documents to determine gaps and establish protocols to remediate identified gaps.
• Organize R&D documents and present them to designated Subject Matter Expert (SME).
• Ensure all active products under Surgical Design Control are compliant to design control requirements established in MDD 93 / 42 / EEC, ISO 13485 : 2016 and MDR EU2017 / 745.
• Bring forth legacy products and their independent documentation to current design control requirements
• Prioritized focus on products that present higher risk to associated EU risk level

Mandatory Requirements

Term & Start