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Compliance Engineer


Skills Required :
Issue and Complaint Management is a group within Bayer Radiology Product Supply that is
responsible for several regulatory and compliance based activities. These include Risk
Management, CAPA, Product Analysis, Recall, and Complaint Handling.
Position Summary:
Engineer - Issue & Complaint Management
This individual is responsible for deliverables and activities in support of the Issue &
Complaint Management group within Bayer Radiology Devices. Success in this role will be
directly related to individual’s ability to effectively engage, learn, and deliver high quality
output while working with multiple stakeholders and team members.
Position Duties & Responsibilities:
• Data analysis and reporting
• Metrics and trending
• Engineering investigations, assessments and reporting ( e.g. Complaints/Root Cause
Analysis)
• Electronic document management and SAP support
• Field Corrective Action coordination/management
Requirements/Preferences Education Requirement (S):
Technical / Behavioral Requirements:
• Bachelor of Science or Engineering degree.
• Compliance/Quality System understanding in regulated environment preferred (e.g. ISO
13485, MDD, MDR, and EN ISO 14971)
• Understanding of Design Control requirements in the medical device industry preferred (21
CFR 820.30)
• Solid foundation in quality engineering methods/tools preferred (e.g. Six Sigma, Pareto,
FMEA, Fishbone)
• Excellent communication skills (verbal and written)
• Strong leadership skills
• Strong cross-functional ability
• Self-motivated/self-directed/self-learner
• Continuous improvement focus

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