Senior Design Quality Engineer – Medical Devices

00006 HILL-ROM SERVICES, INC. USA; Batesville (IN); On-site; USD 96,000 - 132,000; Full time

Benefits offered by this job

Shift flexibility

Medical, Dental and Vision coverage

160 hours of Paid Time Off and Paid H.

401K match

Employee Stock Purchase Plan

Paid Parental Leave

Tuition Reimbursement

Job summary

Baxter in the United States seeks a Senior Engineer, Design Quality to partner on New Product Development and Sustaining Engineering projects. You will oversee quality throughout the product lifecycle, ensure design controls and regulatory compliance, and work with cross-functional teams to mitigate risks and deliver safe, effective medical devices.

You will join a collaborative Quality team that supports R&D, Regulatory Affairs, Manufacturing, and Supplier Quality to bring innovative healthcare

Qualifications

• Bachelor’s degree in engineering.
• 3–5 years experience in quality for medical devices or regulated industry.
• Strong problem-solving and root-cause analysis.
• Knowledge of ISO 13485, ISO 14971, FDA QSR and related standards.
• Experience with design controls and product lifecycle management.
• Auditing or regulatory inspection experience preferred.
• Professional quality certification preferred.

Responsibilities

• Provide quality support and oversight via staff supervision.
• Assess regulatory and quality risk per rules and Baxter practices.
• Support product design activities: DDP, Design Input/Output, reviews, verification/validation, transfer, changes.
• Maintain Design History File in collaboration with R&D.
• Collaborate with Sustaining Engineering and R&D to ensure robust design reviews.

Skills

Quality engineering

Regulatory compliance

Root cause analysis

Design controls

Statistical methods

Education

Bachelor's degree in engineering

Job description

Baxter in the United States seeks a Senior Engineer, Design Quality to partner on New Product Development and Sustaining Engineering projects. You will oversee quality throughout the product lifecycle, ensure design controls and regulatory compliance, and work with cross-functional teams to mitigate risks and deliver safe, effective medical devices.

You will join a collaborative Quality team that supports R&D, Regulatory Affairs, Manufacturing, and Supplier Quality to bring innovative healthcare