Lead Quality Engineer – Medical Devices & Compliance

Baxter Healthcare; Saint Paul (MN); On-site; USD 112,000 - 154,000; Full time

Benefits offered by this job

Medical and dental coverage

401(k) with company matching

Employee Stock Purchase Plan (ESPP)

Paid holidays and PTO 20–35 days

Job summary

Baxter Healthcare is seeking a Principal Quality Engineer in Minnesota to lead strategic quality initiatives across manufacturing and product development. You will apply advanced quality principles to solve complex challenges while guiding cross-functional teams and ensuring regulatory compliance.

The role demands deep knowledge of FDA QSR, ISO 13485, and risk management, with emphasis on CAPA, design controls, and process validation.

Qualifications

• Bachelor's degree in Engineering or related field.
• 5-8 years of Quality Engineering in regulated industries.
• Strong knowledge of FDA QSR 21 CFR Part 820, ISO 13485, ISO 14971, and cGMP.

Responsibilities

• Serve as lead Quality Engineering representative for complex manufacturing and product development initiatives.
• Provide strategic quality leadership for production, process development, and transfers.
• Lead investigations for nonconforming product, CAPAs, and supplier issues with root-cause analysis.
• Act as technical authority for risk assessments, design transfer, controls, validation strategies, and compliance decisions.
• Lead multi-functional teams to resolve quality, manufacturing, and regulatory issues.
• Support supplier quality with qualification, auditing, and performance management.
• Drive quality system improvements through data analysis, KPI tracking, and Lean Six Sigma practices.
• Mentor engineers and cross-functional staff in quality principles.

Skills

Quality leadership

FDA QSR

ISO 13485

cGMP

CAPA

Nonconformance

Design Controls

Injection Molding

Risk Management

Data analysis

Education

Bachelor's degree in Engineering

Job description

Baxter Healthcare is seeking a Principal Quality Engineer in Minnesota to lead strategic quality initiatives across manufacturing and product development. You will apply advanced quality principles to solve complex challenges while guiding cross-functional teams and ensuring regulatory compliance.

The role demands deep knowledge of FDA QSR, ISO 13485, and risk management, with emphasis on CAPA, design controls, and process validation.