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)