Quality Engineer

This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride. 

Your Role at Baxter

This is where your creativity addresses challenges

You are creative, thorough, and a heads-down do-er. You embrace a challenge and truly apply the collaborative powers of your team to produce great results. You are motivated by work that is never the same from one day to the next. As aQuality Engineer, you are unafraid of navigating through necessary internal processes to facilitate a product you deeply believe in. You can absorb and act on complex procedures and data and train your team or peers if needed. You take pride in getting things done quickly without sacrificing safety or quality.

Your Team at Baxter

Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation.

The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.

The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves, so does the way our team approaches work as it strives to create top-of-the-line products.

We build relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable. We feel empowered to speak up when there's a new insight or opportunity to improve something. This open dialog builds trust within the team and helps create a better product for our customers.

What we offer from day 1:

• Vacation and Paid Holidays
• Medical, Dental, Disability and Life Insurance coverage
• Vision and Voluntary Benefits
• Paid Parental Leave
• Retirement Savings Plan – 165E
• Employee Stock Purchase Program
• Educational Assistance Plan

What you'll be doing

• Responsible for the Supplier Quality Assurance process. Ensure that projects within assigned areas comply to government regulations and company policies and procedures. Creates and improves Change Control, Standard Operation Procedures (SOP's) and Protocols, to assure that the company complies with all internal and external global standards for product, process, equipment and systems. This position will be considered SME for critical business controls.
• Perform Change Control task assessment related to Supplier Quality area.
• Perform COUPA requisition quality revision and approval.
• Conduct external supplier audits and reports.
• Lead supplier audit process, generate agenda, and perform audit report.
• Support Quality investigation as required.
• Maintain area procedures updated and in alignment with regulatory requirements and company policies.
• Process documents in TcU system for revision and approval.
• Generate APQR and Management Review reports.
• Perform supplier qualification as required for new suppliers.
• Perform supplier maintenance requirements in SQLM system.
• Generate SCAR report as required.
• Follow up Supplier response and close SCAR records.
• Lead Supplier meetings related to any Quality issue.
• Perform parts approval as required in SQLM system.
• Conduct nonconformance investigations for quality areas as necessary.
• Improve manufacturing processes using analytical tools and Design of Experiments as required.
• Identify supplier issues and work with them to implement corrective actions.
• Coordinate a functional team for special projects. Includes perform team meetings, track progress, action items and deliverables. Report results to management as required by supervisor.
• Perform quality oversight to ensure compliance in area of responsibility.
• Provide quality requirements for change control, validations, and investigation activities.
• Fill out and reviews documentation in compliance with cGMP's and cGDP's.
• Maintain full compliance of quality systems, and cGMP in areas of responsibility.
• Should be able to work at any shift when required.

What you'll bring

• Bachelor’s degree (BS) in engineering; state engineering license & active member of C.I.A.P.R. (desirable) one to three years of experience in medical devices or pharmaceutical operations desirable. Experience in equipment, process, systems and or computerized systems validation. CQE (desirable). Fully bilingual, English and Spanish. ISO 9001current version and 21 CFR Regulation Part 210 and 211 and or Part 820 (desirable).

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

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