Principal Engineer, Quality, Baxter

Principal Engineer, Quality

Baxter

Location:

United States, Batesville

Category:

Manufacturing

Contract Type:

Employment contract

Salary:

104000.00 - 143000.00 USD / Year

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Job Description:

The Principal Engineer will be supporting quality and regulatory matters related to medical bed devices, overseeing various Quality Engineering functions, ensuring compliance with QSR regulations and related policies, and working on data-driven solutions to improve entity quality and monitor key performance indicators.

Job Responsibility:

Serve as a primary point of contact for quality related matters associated with support for medical bed devices
Collaborate with supplier’s engineering and quality organizations to efficiently address reported problems impacting functionality, quality, and regulatory requirements
Work with design engineering to determine receiving inspection requirements of purchased components and finished product
Provide technical quality engineering support to receiving inspection
Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, & PQ)
Participate in Corrective Action System activities including evaluation of failure investigation and corrective action plans, root cause analysis and follow-up activities
Ensure accurate and timely processing of all Quality Records along with the company’s regulatory compliance profile per 21CFR820 regulations
Collect, analyze, and track key data across the Batesville manufacturing site related to entity quality and monitor key performance indicators by working with key partners across the corporation
Use quality tools and practices to establish approval criteria to ensure the identification of quality failure concerns for both internal and external manufactured parts and assemblies (e.g., FMEA (Failure Modes Effects Analysis).

Requirements:

Bachelor's Degree in Engineering required
5+ years of experience in Quality, Manufacturing, or related field
Supervisor/Manager experience preferred
Proficient with Quality System Regulations, MDR, and ISO Quality System Standards
Strong understanding of ISO 13485 preferably
Excellent analytical decision-making and problem-solving skills
Proven ability to resolve issues and participate in process improvement activities
Track record of successful business and customer orientation
Ability to define problems, collect data, establish facts and draw conclusions
Ability to effectively present information in one-on-one and small group situations
Applicants must be authorized to work for any employer in the U.S.

Nice to have:

Supervisor/Manager experience preferred
Strong understanding of ISO 13485 preferably

What we offer:

Support for Parents
Continuing Education/Professional Development
Employee Health & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan
Flexible Spending Accounts
educational assistance programs
time-off benefits
paid holidays
paid parental leave
commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)
childcare benefits.

Additional Information:

Job Posted:

March 20, 2025

Employment Type:

Fulltime

Work Type:

On-site work

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