Job Abstract

•    Evaluate product issues to ensure patient, user and security risk are assessed, and acting as the lead Design Quality Engineer for Post-Market Design Changes on Capital Hardware
•    Update DFMEA and DHF documents as needed as part of the post market design change management process 
•    Provide comprehensive support to Post Market Development Teams with a focus on Design Quality and Risk Management
•    Collaborate with different departments across the organization to understand and review data to assess the patient/user risk associated with the post market life-cycle phase
•    Support Complaint trending and Severity trending signal dispositions
•    Maintain risk management file throughout product lifecycle, ensuring the latest knowledge on risk reflected in the risk documentation
•    Assure compliance to organizational procedures, regulatory requirements and industry standards, and timely completion of assigned CAPAs and audit findings
•    Makes decisions and proposes solutions based on calculated risks identified through data analysis
•    Assist with protocol and implement process validation procedures in accordance with QSR, FDA and international guidelines
•    Coordinate activities through the Quality Engineering Manager and report regularly on the progress of activities

Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience
•    Excellent communication and technical writing skills
•    Experience in Manufacturing and/or Electro-Mechanical Medical Device risk assessments
•    Working knowledge of Quality System Regulation (QSR 21 CFR 820) and EU Medical Device Directive (EU MDD 93/42 EEC)