Key skills
CLeadershipRisk ManagementChange ManagementCommunication
About this role
Role Overview
- Responsible for implementation of quality assurance principles and practices for design, development, manufacturing, and lifecycle management of Tempus’ assay products
- Responsible for core team oversight of Class 3 US FDA and Class C EU IVDR compliance
- Responsible for ownership of the EU PMS framework and related deliverables
- Responsible for identifying PMS trends for Management Review
- Responsible for coordinating cross-functional efforts for the creation and maintenance of DHF and IVDR Technical Documentation
- Responsible for investigational device development, clinical performance, and lifecycle management according to US FDA and EU IVDR requirements
- Ensure the relevance, adequacy, and effectiveness of Tempus’ QMS and its continuous improvement
- Implement risk management principles per ISO 14971
- Maintain and execute change management process
- Apply medical device quality system knowledge as part of quality leadership
- Participate in internal and external quality system audits as required
- Participate in root cause investigations as quality events/incidents arise
Requirements
- 5+ years of experience in the Medical Device/Pharmaceutical regulated industry
- BS degree in Engineering field such as Biomedical, Bioengineering or Chemical Engineering
- Experience with applicable FDA, European and other relevant clinical/regulatory requirements, international standards, including ISO 13485, ISO 14971, EU IVDR/MDR and 21 CFR 820
- Experience in managing FDA or EU pre-market development and post-market surveillance activities
- Excellent oral and written communication skills and can communicate at multiple levels in the organization
- Proficient in Microsoft Office (Word, PowerPoint, Excel, etc.)
- Proficient in eQMS systems (Jama, ComplianceQuest, Pilgrim SmartSolve, etc.)
Benefits
- incentive compensation
- restricted stock units
- medical and other benefits