Senior Design Quality Engineer - Impact Medical Devices

Baxter International; Batesville (IN); On-site; USD 96,000 - 132,000; Full time

Benefits offered by this job

Shift flexibility

Medical, dental, and vision

Paid time off

401K match

Employee stock purchase program

Paid parental leave

Tuition reimbursement

Job summary

Baxter International in Batesville, Indiana, is seeking a Senior Engineer, Design Quality to provide quality oversight across the product lifecycle for New Product Development and Sustaining Engineering projects.

You will collaborate with cross‑functional teams to ensure design controls, regulatory requirements, and quality standards are met, mitigating risks and delivering compliant medical devices.

Qualifications

• Bachelor’s degree in engineering or equivalent required.
• 3–5 years of quality experience in medical devices or similarly regulated industry.
• Strong understanding of design controls and product lifecycle management.

Responsibilities

• Provide quality support and oversight through direct staff supervision or area responsibilities.
• Identify and assess regulatory and quality risks in activities and processes per FDA/ISO rules.
• Support product design activities including Design Verification and Validation, Design Review, and Design Transfer.
• Maintain and compile Design History Files with R&D collaboration.
• Collaborate with Sustaining Engineering and R&D to ensure robust design reviews.

Skills

Quality engineering

Regulatory compliance

Design controls

Risk management

Root cause analysis

Statistical methods

Cross-functional collaboration

Problem solving

Written and verbal communication

Quality lifecycle management

Education

Bachelor’s degree in engineering

Tools

ISO 13485/14971 knowledge

FDA 21 CFR Part 820 familiarity

Job description

Baxter International in Batesville, Indiana, is seeking a Senior Engineer, Design Quality to provide quality oversight across the product lifecycle for New Product Development and Sustaining Engineering projects.

You will collaborate with cross‑functional teams to ensure design controls, regulatory requirements, and quality standards are met, mitigating risks and delivering compliant medical devices.