Sr Engineer, Quality Assurance

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 Senior Quality Engineer provides engineering support to the plant through batch release, nonconformance investigation, process optimization, risk management, validation, defect prevention, project management, and technical evaluations. This role ensures product/process compliance with all applicable standards and regulations.

Your team

The Engineering team is comprised of inquisitive individuals who adopt a collaborative approach and tackle sophisticated challenges that meet the needs of our patients. We often need to change directions and respond to issues to avoid disruptions in our fast-paced manufacturing environment. Together, we build and maintain a positive work environment.

We provide opportunities for you to continue to learn through training, conferences, certifications, and support for advanced degrees. Growth from role to role or level to level is encouraged and is supported by management to ensure employees are consistently engaged with their work. Our benefits enable you to better yourself and plan for your future as we offer tuition reimbursement, a generous 401k match program, and comprehensive health benefits for you and others who count on you.

What you'll be doing

• Support batch release through root cause analysis, investigation and process optimization.

• Conduct nonconformance and CAPA investigations with use of problem-solving techniques and technical writing skills.

• Supports the manufacturing plant through implementation of process improvements.

• Lead small projects (both new and improvement) to include cost, implementation, and validation.

• Evaluates sampling/ testing/ qualification plans with respect to current quality levels and test methods.

• Composes protocols, final reports, studies, experiments, and general information reports for use by management.

• Assist in evaluation of customer complaints, risk management and technical summaries.

• Assure compliance of manufacturing and quality control operations with respect to corporate specifications, SOP's, Good Manufacturing Practices/Quality System Regulations (FDA 21CFR 210-211,820), Corporate Quality Manual (CQM), ISO 13485:2016, and other applicable standards and regulations.

What you'll bring

• Bachelor's Degree required in Engineering.

• 3-5 years' experience in Quality a pharmaceutical or medical device organization or a similar regulated industry. Other relevant experience outside of Quality but in a regulated industry may be considered.

• Experience in manufacturing, particularly with a focus on adhering to relevant medical device regulations (21CFR820, 1SO13485, CMDR, MOD), is highly desirable.

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 employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $88,000- $121,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

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.

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.