Principal Quality Engineer
Baxter · St Paul, MN
QualityFull-time$112k–$154kCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Baxter seeks a Principal Quality Engineer to serve as a senior technical leader in the Quality organization. This role provides strategic quality direction for complex manufacturing, new product development, and continuous improvement while mentoring quality professionals and influencing cross-functional decisions.
What they're looking for
- Bachelor's degree in Engineering, Science, or related technical field
- 5-8 years of Quality Engineering experience in regulated medical device, biologics, or pharmaceutical industries
- Demonstrated technical leadership for complex quality and compliance initiatives
- Extensive knowledge of FDA QSR (21 CFR Part 820), ISO 13485, ISO 14971, cGMP, and risk management
- Advanced experience with CAPA, nonconformance management, change control, supplier quality, and design controls
- Experience supporting injection molding manufacturing in regulated environments
- Strong analytical, statistical, and problem-solving skills with multi-functional leadership ability
What you'll be doing
- Lead quality engineering for complex manufacturing, product development, and process improvement initiatives
- Serve as technical authority for risk assessments, design transfers, process controls, and compliance decisions
- Lead investigations of nonconforming product, complaints, CAPAs, and deviations using advanced root cause methodologies
- Establish quality plans, risk management files, inspection strategies, and process monitoring systems
- Represent Quality during regulatory inspections, customer audits, and support lead audit programs
Privacy & handoff
This role links to Baxter's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.