Sterilization Quality Engineer

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

This is where your creativity addresses challenges

This position is a key role in the Quality organization. Primary areas of responsibility will be on-site and off-site sterilization and managing subordinates in these areas. This role is responsible for carrying out duties in accordance with the organization's policies and applicable laws.

Responsibilities will include implementation of the quality systems, processes and procedures in the sterilization departments. This role is responsible for training employees; planning, assigning, directing and driving work; and resolving problems.

Additional focus will be on implementing continuous improvement, supporting equipment/system upgrades and new equipment/systems. Multi-functional collaboration will be involved in this role as well.

Your Team at Baxter

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 60 years. The work is challenging and rewarding, as Baxter offers competitive compensation and benefits. Baxter encourages and values every employee and believes that all can make a contribution to advancing healthcare for patients; work to be proud of.

What we offer from Day One

• Medical, Dental and Vision coverage
• 160 hours of Paid Time Off and Paid Holidays
• 401K match
• Employee Stock Purchase Program
• Paid Parental Leave
• Tuition Reimbursement

What you'll be doing

• Responsible for the scheduling of sterilization services in house and with Contract Sterilizers.
• Responsible for sterilization qualification and requalification scheduling and execution of studies.
• Responsible for scheduling and execution of temperature mapping studies across the facility.
• Must perform process validation, process capability, and process control studies for assigned 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/technology.
• Analyze and assess current systems to assure regulatory compliance.
• Facilitate the validation status of key process equipment.
• Plan and prioritize different projects to ensure completion within the target dates.
• Perform failure investigations and track follow-up corrective actions as indicated.
• Must assist in the identification and development of process improvement projects including automation and computerization.
• Responsible for ensuring FDA regulations are met for system upgrades/replacements.
• Ability to function optimally as a member of a team.
• Ability to communicate optimally in written and verbal form.
• Responsible for Specification/SOP compliance for sterilization processes (EO, gamma, steam)
• Evaluate and assist in ways to improve supplier and plant processing characteristics to improve the quality and cost of sterilized products.
• Support and assist in activities to assure products’ sterility is maintained.
• Responsible for Quality management activities in supporting the plant unreleased and released sterilized products.
• Must perform other duties and responsibilities as determined by supervision/management.
• Must have knowledge of both plant and departmental environmental health and safety regulations and align with said regulations accordingly.
• Some Travel required.

What you'll bring

• BS degree in Engineering Subject area and 3-5 years related experience
• Leadership skills.
• Ability to work independently
• Strong team leadership skills
• Ability to work with a diversified multi-functional team across within and outside the facility.
• Strong written and communication skills
• Logical thought process and consistently exercise discretion and judgment
• Self-motivated and work well without direct supervision.
• Ability to quickly learn and understand applications.
• Meet visual acuity requirements as documented in the Baxter Cleveland Visual Acuity Procedure CL-01-01-037.
• Ability to lift to 10 pounds
• Ability to sit, stand and/or walk for long periods of time
• Ability to reach above the shoulder
• Ability to bend/stoop
• Knowledge of applications such as Wonderware, Allen-Bradley PLC, Microsoft Project preferred.
• Sterility Assurance or Pharmaceutical industry experience desired
• Previous experience desired with EO, Gamma Irradiation, and/or Steam Sterilization
• ASQ Certification (CQE or CSQE), Green Belt Certification, Black Belt Certification or equivalent desired.

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 $104,000 - $143,000 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.

LI-BAXGEN

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

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