Join to apply for the Senior Quality Engineer - PMS role at Tempus AI
Recent advancements in technology have enabled AI to impact clinical care significantly. Tempus' platform connects real-world evidence to deliver real-time insights to physicians, aiding in selecting appropriate treatments for patients.
We seek a Senior Quality Engineer – PMS with expertise in FDA Quality System Regulation (21 CFR 820), ISO 13485, and experience with CAP/CLIA and New York State regulations, especially in laboratory-developed tests (LDTs). The role involves supporting quality metrics, resolving non-conformances, leading Post-Market Surveillance activities, and ensuring compliance across global markets.
Responsibilities
- Assist in Quality Data trending and monitoring within QA
- Develop reporting strategies and metrics for Quality Management Review
- Implement metric reporting across operations
- Lead Major incident management and cross-functional resolution
- Support Post Market Surveillance procedures and processes
- Trend control limits and assay quality data with Operations
- Lead international product risk management activities
- Support complaint analyses, failure investigations, adverse event reporting, and field actions
- Collaborate with complaint handling and data analysis teams for trending and signal detection
- Assist in creating post market plans and reports, and communicate findings to leadership
- Support regulatory reporting and respond to authorities’ requests
- Participate in CAPA investigations and audits
Qualifications
- Bachelor's degree in Biology, Chemistry, or related field
- 5+ years in medical device, IVD, or pharmaceutical industry
- Expertise in Quality Systems, Engineering, Assurance, and Metrics
- Strong collaboration and communication skills
- Knowledge of FDA QSR, GMP, ISO 13485:2016, ISO 14971, MDSAP, and EU-IVDR is a plus
- Experience with PMS, IVD/MD Vigilance reporting, and regulatory audits is a plus
Salary ranges vary by location, with benefits included. Tempus is an equal opportunity employer.
Additional Details
- Seniority level: Mid-Senior level
- Employment type: Full-time
- Job function: Quality Assurance