Instrument Design QA Lead

What you will do

Quality assure design controls across the product lifecycle, reviewing and approving verification and validation plans and results, and keeping design inputs, outputs and traceability coherent across the family.
Lead design reviews and risk management for your product family, owning the ISO 14971 lifecycle from hazard identification through residual risk evaluation and benefit-risk analysis, with a pragmatic and engineering-driven approach.
Facilitate and quality assure change management, with the engineering teams driving their own design and medical device changes and you making sure each one is properly assessed, documented, reviewed and approved.
Coordinate design transfer with Manufacturing QA and Production Engineering, moving designs into manufacturing with the evidence and controls in place.
Quality assure the technical documentation and medical device file for your product family, keeping them complete, current and audit-ready under EU MDR and the FDA QMSR.
Act as QA subject matter expert in internal and external audits, covering design quality, design controls and design transfer.

Quality assure design controls across the product lifecycle, reviewing and approving verification and validation plans and results, and keeping design inputs, outputs and traceability coherent across the family.
Lead design reviews and risk management for your product family, owning the ISO 14971 lifecycle from hazard identification through residual risk evaluation and benefit-risk analysis, with a pragmatic and engineering-driven approach.
Facilitate and quality assure change management, with the engineering teams driving their own design and medical device changes and you making sure each one is properly assessed, documented, reviewed and approved.
Coordinate design transfer with Manufacturing QA and Production Engineering, moving designs into manufacturing with the evidence and controls in place.
Quality assure the technical documentation and medical device file for your product family, keeping them complete, current and audit-ready under EU MDR and the FDA QMSR.
Act as QA subject matter expert in internal and external audits, covering design quality, design controls and design transfer.