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Product Quality Engineer (Mid & Senior Level)

Req #: JR - 075777 Location Acton, Massachusetts, United States Job Category: Quality Control Date Posted: 07/29/2022

Overview

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

  • Support for Parents

  • Continuing Education/
    Professional Development

  • Employee Health &
    Well-Being Benefits

  • Paid Time Off

  • 2 Days a Year to Volunteer

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Success Profile

What makes a successful Quality team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

  • Detail Oriented
  • Continuous Learner
  • Courageous
  • Collaborative
  • Critical Thinker
  • Influential

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Product Quality Engineer (Mid & Senior Level)

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. 

Scope:
• Established professional with a track record of success in area of expertise
• Advanced understanding of area(s) of specialization; understands consequences of decisions on other functions
• Ownership and accountability for site complaints and it investigation.
• Expected to proactively investigate and deliver continuous improvement within their function or process
• Expected to be aware of best or emerging practice in their area of specialization
• Provide direction or guidance to peers or junior employees

Job Complexity
• Works on assignments of broad scope and advanced complexity (“can do it all” in their area of specialization)
• High level analytical skills to identify improvement opportunities and implementation of solution; proven record of delivering same
• Demonstrated initiative to manage multiple and/or diverse processes, deliverables, or services
• Reprioritizes own work as necessary, negotiating as required, to accomplish objectives and ensure alignment to function’s goals
• Wide latitude to demonstrate independent judgment and make decisions
• Continually gains, applies and shares new knowledge/skills

Influence, Impact, Interaction
• Regular interaction across functions and sites; actively collaborates with peers to foster cross functional results
• Significant influence within own function, and other functions
• Recognized as the “go to” person for all site product complaints at the site
• Established internal network and external contacts in own area of expertise
• Proactively builds and leverages key relationships to gain cooperation without formal authority
• Decisions will have significant impact own function/department, will impact other functions/departments

Supervision
• Acts with autonomy in area of responsibility, plans own work, resources and priorities; consults with manger on unusual situations
• Knows “how to get everything done” on their own; acts independently; little need for guidance from other staff
• Annual objectives are solution oriented and relate to most complex aspects of program or process; exercises independent judgment to ensure alignment with the overall business strategy


Education and Experience
• Bachelor of Science in Engineering or related technical field required. Master’s degree preferred.
• 3-4 years of medical device industry experience in a quality department role is preferred. (1-2 years of experience with master’s degree)
• Knowledge of US medical device regulations (21 CFR Parts 820, 803, 806, ISO 13485, Medical Device Directive, Canadian Medical Device Regulation) preferred.

Qualifications and Skills

• Plans, coordinates, and directs quality assurance system support efforts to meet the needs of production operations.
• Monitoring and Trending Duties:Administers, supervises, and executes the Quality Systems in complaint management areas.
• Conducts tend analyses and associated reports to management.These analyses will include, but are not limited to complaints and other data requested and monitored by management.
• Applies problem solving and quality improvement tools and techniques, including, preventative and corrective actions and how to overcome barriers to quality improvements.
• Acquires and analyzes data using appropriate standard quantitative methods to facilitate process analysis and improvements.
• Quality experience in medical device or related GMP environment preferred.
• Fluency in English language required.
• ASQ certification (Certified Quality Engineer, Certified Quality Auditor, Certified Biomedical Auditor) a plus.

#LI-RT1

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

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.

EEO is the Law 
EEO is the law - Poster Supplement
Pay Transparency Policy

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.

075777

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Christelle, Senior Quality Manager in Malta

"I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need."

Christelle

Meet Lorena, Senior QA Associate in London, UK

"I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety."

Lorena

Meet Gary, Quality Research Manager in Singapore

"I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission."

Gary

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Christelle

Meet Christelle, Senior Quality Manager in Malta

"I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need."

Lorena

Meet Lorena, Senior QA Associate in London, UK

"I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety."

Gary

Meet Gary, Quality Research Manager in Singapore

"I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission."

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