Principal Quality Engineer

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. 

Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. 

Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission. 

Your Role at Baxter!

The Principal Quality Engineer applies a solid understanding of theories/practices applied by other fields outside the primary area of expertise toward the development of new or enhanced products or Quality processes. The person in this role plans, implements and functionally advises important engineering assignments, which require independent judgment.

What you will be doing

• Applies innovative techniques in the area of expertise to develop new or improved products and processes
• May lead a large scale program or several small projects with sophisticated features
• Independently plans, schedules and leads cross-functional team in detailed phases of the Quality work in a project
• Identifies and manages continuous improvement projects with the objective of achieving quality, reliability and cost improvement
• Lead audit ready status efforts for assigned areas and assist other areas within the facility in understanding FDA, ISO and Baxter quality requirements
• Maintain a high level of expertise in current regulatory requirements, and serve as a plant resource for compliance to these requirements
• Lead in the development of customer awareness and understanding activities for areas of direct responsibility, and where appropriate, assist and support such activities throughout the facility
• Take lead role in NCR/CAPA activities such as investigation, implementation, or verification of effectiveness
• Support risk management activities as they relate to product and post market surveillance.
• Provide product quality support on new product development, risk management, design transfer and sustaining engineering core team
• Work collaboratively with R&D to develop Product Design Requirement and & Test Methods for successful Design Verification and Validation
• Defend/support product design history file (DHF) in internal and external audits
• Provide PQ support to 510(k) submission, product launches, product recalls/field actions, NCRs and CAPA investigations

What do you bring

• B.S. degree in Engineering
• Minimum of 6 years’ experience in Quality, Manufacturing, Engineering or related field
• Demonstrated success in delivering results on several technical/product/Quality challenges
• ASQ and/or Six Sigma Blackbelt Certification preferred
• Product development experience with medical devices preferred
• Proficient in relevant products or process development processes (i.e. NPD and sustaining-life cycle management)
• Must have experience with crafting/managing Design History File (DHF) and Risk Management File (RMF)
• Demonstrates leadership skills to handle sustaining product support activities involving Complaint investigations, Trigger evaluations and Change controls
• Good project management skills
• Recognized as a technical expert by peers and other personnel within the business unit
• Extensive multi-functional team experience, including technical and non-technical work
• Ability to coordinate and present technical and project mgt. overviews without assistance
• Solid understanding of FDA Regulations (e.g. 21 CFR Part 820), Application of Good Laboratory Practices, Application of Good Manufacturing Practices, ISO (e.g. ISO13485 and ISO14971) and other applicable standards (e.g. IEC60601 and IEC62304 electromechanical medical device) and ISO 22442 (Med Devices using animal tissues) and regulatory requirements (e.g., EU MDD and MDR)

Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all our employees, and we strive to be more transparent with our pay practices. To that end, this position has a base salary range of $104,000 to $143,000, plus an annual incentive bonus, commission target, and equity target. The above range represents the expected base salary range for this position. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in the role, business line, and geographic/office location.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

US Benefits at Baxter (except for Puerto Rico)

This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Know Your Rights: Workplace Discrimination is Illegal

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.