Quality Systems Analyst I

This is whereyour 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.

Provide Quality support and oversight of process/area responsibilities. Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Baxter quality practices. Conducts reviews of documentation and reports for conformance to procedures, protocols and regulatory requirements.

Cleveland's technology and automation are innovative. It is the U.S. sole source for plastic pour bottles, glass IV, and various reconstitution devices. This facility has a number of major product lines with a diverse array of automated manufacturing technologies ranging from bottle solution filling, injection molding, and device assembly.

Our Cleveland plant has been an integral part of Baxter for over 70 years. The work is challenging and rewarding, as Baxter offers competitive compensation and benefits. Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

• Medical, Dental and Vision coverage
• 160 hours of Paid Time Off and Paid Holidays (Part-Time will be prorated based on the hours you work)
• 401K match
• Employee Stock Purchase Program
• Paid Parental Leave
• Tuition Reimbursement

• Must perform equipment qualification, test method and process validation activities, process capability and process control studies for assigned areas.
• Must plan and implement software validation activities in manufacturing and support areas.
• Must drive quality/manufacturing projects applying Lean, problem solving, process control, and project management tools to achieve and sustain operational excellence.
• Must support Manufacturing, Engineering, and Quality Management departments with the development and implementation of new processes/technologies.
• Must assist in the identification and development of process improvement projects including automation and computerization.
• Must ensure computer systems and applications are aligned with regulatory quality standards through validation activities. May serve as SME for Computerized System Validation processes.
• Responsible for ensuring FDA regulations are met for system upgrades/replacements.
• Responsible for audits, creation, and implementation of Specifications/SOPs.
• Responsible for ensuring the quality of facility systems (validation):
• Writing and implementing protocols and test cases for validations.
• Coordinating testing and documentation of projects.
• Documenting/implementing changes to applications.
• Assisting/leading training for systems.
• Diversified knowledge of applied Statistical Analysis techniques, procedures, and criteria to carry out measurements, process, and product capability studies for the development of new or refined equipment, materials, processes, instruments, and products.
• Must perform failure investigations and track follow-up corrective actions.
• Ability to function effectively as a member of a team.
• Ability to plan and prioritize multiple projects to ensure completion within the target dates.
• Ability to communicate effectively in written and verbal form.
• Must have knowledge of both plant and department environmental health and safety regulations and follow said regulations accordingly.
• Must perform all other duties and responsibilities as determined by supervision/management.

• BS degree in Engineering, Computer Science or other core Science Subject area and 3-5 years minimum related experience (in house, co-op or acquired outside).
• Knowledge of applications such as Wonderware, Allen-Bradley PLC/HMI, Access, Microsoft Project preferred.
• Basic knowledge of manufacturing processes and the ability to quickly learn and understand processes/applications.
• ASQ Certification (CQE or CSQE) or equivalent desired.
• Leadership skills.
• Ability to work independently or with a diversified cross functional team across different locations.
• Ability to mentor new Engineers to the Company.
• Logical thought process.
• Self-motivated and works well without direct supervision.
• Quality Assurance or Pharmaceutical industry experience desired.
• Ability to lift to 10 pounds, to sit, stand and/or walk for long periods of time.
• Ability to reach above the shoulder, to bend/stoop.

Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

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 $80,000 - $110,000 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, commission, and/or long-term incentive. 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.

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.

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