Senior Quality Engineer

This is whereyour work makes a difference.

At Baxter we believe every personregardless of who they are or where they are fromdeserves 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 jobyou will find purpose and pride.

Your Role:

Provide Quality Engineering support to manufacturing and new product development teams through Engineering Investigations Qualifications and Validations. Identify quality issues participate in quality improvement projects and quality activities that impact manufacturing. Other related activities include: maintenance of on-going stability validations non-conforming material investigations maintenance of risk management documentation and corrective and preventive actions when required.

What Youll Be Doing:

• Responsible for preparation of written Engineering Investigation Qualification and Validation plans statistical analysis of data and preparation of reports to support manufacturing improvements on-going validations and new product development efforts.

• Provide quality engineering support for manufacturing lines including floor support.

• Investigate and disposition nonconforming material reports (NCR events).

• Initiate investigate and implement corrective and preventive actions as assigned.

• Provide quality engineering support for material nonconformances including supplier corrective actions.

• Support product development teams to develop new products and transfer to manufacturing through participation/leadership of risk management activities performance of component qualifications and execution of test protocols.

• Responsible for coordination of validation activities performed to ensure adherence to specifications and expectations.

• Initiate documentation changes and/or change control for products and processes as required to reflect validation/qualification activities and results.

• Perform internal quality system and supplier audits as assigned.

• Complaint investigations assigned by Product Surveillance or Supervisor.

• Participate in or lead Kaizen or other Lean 6-sigma problem solving projects.

• Other duties as assigned.

What Youll Bring:

• BS in Engineering or related field of science.

• 3 - 5 years of experience in Manufacturing Quality Design Assurance or Quality Systems.

• Excellent oral and written communication skills.

• Strong problem solving technical writing and organizational skills.

• Self-motivated worker persistent curious

• Other duties as assigned.

• Working knowledge of FDA GMP and ISO 13485 requirements.

• Knowledge of statistics and quality tools such as SPC Risk Analysis Process Capability DOE TQM methods and Lean/Six-Sigma.

• Working knowledge of MS Word Excel and Project applications.

• Display a solid technical understanding of engineering principles and procedures.

• Preferred; Sterilization and Process Validation experience.

• Preferred; ASQ Certification in Quality Engineering.

• Preferred; Previous Quality System auditing experience.

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 $88000 - $121000 annually. The estimated salary is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based upon market data and other factors all of which are subject to change. Individual pay is based on 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.

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 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.