QA Engineer (Medical Device)
- Highland Heights, OH
Nextgen Technologies Inc
Location: Highland Heights / Ohio
Experience: 0-3 years professional experience. Education: Bachelor's Degree or Certifications as a CT Scanner/Nuclear Medical Scanner.
• Evaluate, investigate, track and complete complaints through effective and established complaint handling process.
• Ensure accurate documentation of evaluation and investigation results with the assigned complaint records.
• Participate and collaborate objectively with productive conclusions in the Complaint Handling Unit meetings.
• Coordinate with the reportable complaint investigators in providing any missing information for root cause activities.
• Collaborate with Engineering, Customer Support, Field personnel, Market Service Order reviewers and other appropriate groups for adequate initial evaluation of complaints.
• Collaborate with Adverse Event Coordinators for reportable complaints as well as Product Safety Committees for Correction and Removal process.
• Assist in trending of complaints and collaborate with the appropriate groups to ensure that the data gets pushed to the appropriate departments for actions.
• Support reviews and audits assigned.
• Work with the Post Market Surveillance Manager for any other projects assigned.
Candidate MUST have knowledge of Nuclear Medical Scanners or CT Scanners. Preferred candidates will have a background working as a CT Technician or Nuclear Medical Technician. Candidates must be computer literate and must have either a Bachelor's Degree (preferably in Bioscience or Biomedical Engineering) or a certificate as a CT Technologist/Nuclear Medical Technologist.
Bachelor's Degree or Certifications as a CT Scanner/Nuclear Medical Scanner.