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Roles and Responsibilities
Be responsible for delivery of technical content and quality management deliverables.
Required Qualifications
Bachelor’s Degree in Computer Science or in “STEM” Majors (Science, Technology, Engineering and Math).
A minimum of 5 years of technical & professional experience in Medical Device Industry in the capacity of systems engineer/development engineer/Verification lead.
Quality Specific Goals:
Aware of and comply with the GEHC Quality Manual, Quality Management System.
Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position.
Complete all planned Quality & Compliance training within the defined deadlines.
Identify and report any quality or compliance concerns and take immediate corrective action as required.
Drive compliance/closure of Regulatory and Quality requirements before approving.
Design Control FDRs and NPI program milestones.
Identify continuous improvement activities by initiating the implementation of process and product quality improvement initiatives.
Technical Expertise:
Expertise/understands Medical Device Software Design Principals, requirements for meeting various country regulatory clearances, and demonstrates awareness of industry dynamics.
Proven track record of successful problem definition, technical decomposition, and project estimation.
Knowledge of software design principals and cybersecurity principals
Experience in at least one of the following product development activities: Verification/Validation, Defect management , CAPA, Compliant analysis and product surveillance in medical device industry, preferably in Monitoring solutions domain.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
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