Quality Assurance Engineer - Design Quality

Phase End Design Reviews – drives compliance of the review, reviews document and provides DHF reviews.

Provides Software Summary Assessment

Provides Post Market surveillance and customer complaint data for design inputs including; Complaints, CAPAs, Journals, Customer Surveys and Audit Findings.

Obtains and distributes on-going metrics for review by relevant teams:

Number of Recalls – by type

Number of Discrepancy Reports (by priority and phase discovered)

Complaint analysis as pertaining to Design Control

Tracking of scheduled delays (length / cause)

Design Input Requirements

Design Change management

Design Architecture

Risk Management

Defects, complaints

Testing (Design Verification and Validation, protocols and test reports)

Relevant traceability for engineering changes

Design History File

Phase Gate Reviews

Other documents, as requested, such as software summary reports for international regulatory submissions.

We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

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