Sr Quality Engineer

Vantive: A New Company Built On Our Legacy

Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.

At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.

Experience an outstanding opportunity to be a part of a dynamic and ambitious team as a Senior Quality Engineer at Baxter Healthcare Corporation in Plymouth. This role allows you to use your expertise in Quality Engineering within a highly collaborative, innovative, and inclusive workplace dedicated to delivering flawless medical solutions.

What you'll be doing:

• Strictly ensure site compliance with local and global Quality Management System (QMS) Procedures.
• Perform quality-related functions for post-market activities, including Nonconformance Investigation and Corrective and Preventive Action (CAPA) Management.
• Act as a Domain Expert in QMS, offering advice to site personnel on QMS requirements.
• Assist in preparing and hosting internal audits to maintain our world-class standards.
• Prepare and host external audits with regulatory authorities to ensure compliance.
• Review and approve design inputs, outputs, verifications, validations, and design transfers in accordance with QMS requirements.
• Assist in decision-making for process and product improvement efforts, ensuring outstanding quality.
• Write, review, analyze, and revise local QMS documentation to maintain our flawless operational standards.

What you'll bring:

• B.S. in Engineering and a minimum of 3 years of relevant experience in the medical device industry or a similarly regulated industry.
• Demonstrated understanding of Quality Engineering and worldwide Quality System standards and regulations.
• Ability to work under deadlines and changing priorities with minimal supervision.
• Looking for someone who excels in verbal and written communication skills to collaborate effectively in a dynamic organizational environment.
• Strong analytical and problem-solving skills.
• Demonstrated ability to perform within project and investigational environments.

Preferences

• American Society for Quality Certification (e.g., CQE, CQA) and/or Six Sigma certification highly preferred.
• Demonstrated assertiveness and ability to represent the Quality function in various roles supporting R&D engineering activities, including product support and lifecycle management.
• Experience and understanding of Risk Management techniques and principles.

Baxter is dedicated to fostering a workplace that embraces flexibility. Our flexible workplace policy encourages a minimum of 3 days a week onsite, allowing for valuable in-person connections and collaborations while upholding our passionate purpose.

We recognize that compensation is a key factor as you consider your next career move. At Baxter, we are committed to equitable pay for all our employees and strive to be transparent with our pay practices. This position offers a base salary range of $76,000-95,000.00, plus an annual incentive bonus and equity target. The actual salary may vary based on factors including relevant skills/experience, time in the role, business line, and geographic/office location.

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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.
                                                                                                                                                               
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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

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