Senior Principal Medical Software Quality Engineer

1001 Baxter Healthcare Corporation

Raleigh (NC)

Hybrid

USD 128,000 - 176,000

Full time

3 days ago

Be an early applicant

Get a reply from this employer

Your resume and cover letter, tailored to exactly what they’re hiring for.

Get past ATS filters

Benefits offered by this job

Medical and dental coverage

401(k) with company match

Employee Stock Purchase Plan (ESPP)

Paid holidays & PTO

Job summary

Baxter is hiring a Senior Principal Engineer, Software Design Quality to serve as the senior technical authority for software design quality across the product lifecycle. The role focuses on embedded software in electromechanical medical devices, with potential future support for PC-based, web-based, connected, or interoperable software.

You will partner with Software Engineering, Systems Engineering, Regulatory Affairs, Manufacturing, and other teams to establish quality strategies, manage

Qualifications

8+ years of Quality Engineering experience in regulated software.
Experience with software design controls, lifecycle evidence, and risk management.
Proven ability to lead cross-functional teams and make independent, evidence-based decisions.

Responsibilities

Serve as senior Design Quality authority for medical device software.
Provide independent Quality leadership for software development and release decisions.
Lead risk-based quality strategies and ensure traceability across requirements and tests.
Support internal/external audits and regulatory inspections.

Skills

Design quality

Regulatory knowledge

Risk management

Independent decisions

Leadership

Education

Bachelor's/Master's in Software Eng

ASQ Certified QE or equivalent

Tools

Embedded software

Job description

You will partner with Software Engineering, Systems Engineering, Regulatory Affairs, Manufacturing, and other teams to establish quality strategies, manage

Get your free, confidential resume review.

or drag and drop your file here.