Principal Engineer Apply
CorTech is seeking to hire a Principal Engineer for our client in West Palm Beach, FL!
Benefits Available!
Weekly Pay!
$51.17/Hour
Shift: 1st
Description:
Principal Engineer, Quality QMS Remediation
Job Description:
• Responsibility for supporting QMS Remediation activities for a QMS that is geared to support medical device SW only products due to recent internal audit findings
• Supporting the local Quality & R&D team and further departments with Audit responses acc. to internal audit outcomes
• Working on Non-Conformances/CAPA to get to root-cause and implement effective actions
• Improvement of the different QMS to streamline for high priority Software Connectivity projects, that are mostly related to the Design & Development procedures
Qualifications:
• Experience in assessing and developing procedure to meet Software QMS regulatory requirements and guidance’s.
• Experience in the application of design controls and compliance requirements in accordance with 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971, EU MDR, FDA pre and post market cybersecurity guidance, for the development of SaMD product.
• Strong communication and leadership skills.
• Strong, results driven, project management skills.
• Excellent problem-solving skills and the ability to teach others.
• Experience with FDA inspections. ISO/ Notified Body audits is a plus.
• Professional certification such as ASQ, IEEE, Six Sigma, LEAN manufacturing or achievement of certification. ASQ CSQE preferred.
