Overview
On Site
BASED ON EXPERIENCE
Full Time
Contract - Independent
Contract - W2
Skills
Computer Hardware
FMEA
Change Management
Market Development
FOCUS
Collaboration
Risk Management
Documentation
Regulatory Compliance
Auditing
Data Analysis
Quality Assurance
Reporting
Communication
Technical Writing
Manufacturing
Mechanical Engineering
Risk Assessment
Medical Devices
Job Details
Job Description:
* 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
* 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
Qualification:
* Bachelors degree required
* 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)
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