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

Save Job

Apply Position

Job Description:

The Principal Engineer will be supporting the quality and regulatory related matters associated with the medical bed devices. You will be responsible for overseeing and/or assisting with various Quality Engineering functions and ensuring compliance with QSR regulations and related policies and procedures.

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

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
Strong understanding of ISO 13485

What we offer:

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 (RSP)
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service
Family and medical leaves of absence
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

View All Jobs In This Company

Job Link Share:

Welcome to CrawlJobs.com –
Your Global Job Discovery Platform

At CrawlJobs.com, we simplify finding your next career opportunity by bringing job listings directly to you from all corners of the web. Using cutting-edge AI and web-crawling technologies, we gather and curate job offers from various sources across the globe, ensuring you have access to the most up-to-date job listings in one place.