Quality Engineer developing and deploying core infrastructure modules for Veeva Vault. Contributing to testing strategies and collaborating in a fast - paced engineering environment.
About the role
- Lead Quality Engineer at Tempus implementing quality assurance for regulated medical devices and lab developed tests. Overseeing compliance with FDA and EU regulations while collaborating with multidisciplinary teams.
Responsibilities
- 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
Job title
Job type
Experience level
Salary
Degree requirement
Location requirements
Lead Quality Assurance initiatives at Guardian, ensuring regulatory compliance and quality outcomes in healthcare operations. Collaborate with cross - functional teams to oversee credentialing processes and support automation solutions.
Mid - level Software Quality Assurance Engineer working on AI - powered application testing in Aurecon. Collaborate with cross - functional teams and contribute to quality assurance processes.
Frontend QA Engineer responsible for testing web interfaces and client - side logic. Ensuring product stability and enhancing user experience at TradingView with a global user base.
Director of Operations and Service Quality Engineer at Applied Materials focusing on innovative solution delivery. Developing tools and training for quality improvement in semiconductor manufacturing.
Quality Assurance Principal Associate overseeing quality activities in external manufacturing for pharmaceutical company. Liaising with external partners to ensure regulatory compliance and product quality.
Full - Service Reviewer performing estimate and documentation reviews for insurance claims. Collaborating with franchisees and carriers to support service level compliance and operational excellence.
QA Analyst responsible for quality assurance testing of complex software applications for IQVIA. Collaborating with developers and project stakeholders to ensure software quality and performance.
Mechanical/Fluids Design Engineer II at Blue Origin developing systems for testing rocket engines. Designing high - pressure gas and cryogenic fluid systems with oversight of construction and commissioning.
Quality Engineer Intern at TD providing software testing and collaborating with teams on application quality assurance. Contributing to various quality engineering activities with world - class training.