Quality Specialist (8Th Shift: 7Pm-7Am)

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

Responsibilities fall into two main areas: Sterilizer studies and metrology. Assure that sterilization and calibration processes align with Corporate and Plant requirements. Work with manufacturing, maintenance and plant sterilization to assure equipment availability and production efficiency. Provide data for inclusion in reports to regulatory agencies.

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.

What we offer from Day One

• Shift flexibility to trade shifts and leverage overtime opportunities

• 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

Sterilizer Studies

• Conduct qualification, requalification and evaluation studies

• Resolve test requirements based on specification or protocol instructions

• Schedule vessel availability

• Prepare test equipment

• Prepare materials for studies and schedule materials production

• Generate loading patterns using computer program

• Load temperature sensors and test articles per loading pattern

• Perform studies per specification or protocol

• Evaluate results against specification, SOP or protocol requirements

• Identify out of specification/protocol conditions

• Issue exceptions reports

• Analyze data, materials and/or equipment to determine the cause of out of limits or exception conditions

• Determine study acceptability

• Prepare study package for management review and approval

• Review/approve sterilization maintenance requests

Metrology

• Conduct calibrations of critical gauges, meters and monitoring devices per specification or SOP

• Evaluate calibration results

• Make determination of acceptability of calibration by comparing results against specification and SOP requirements

• Identify out-of-tolerance or exception conditions

• Prepare monthly and quarterly trend reports

• Maintain calibration standard equipment

• Work with outside calibration vendors

• Review Maintenance and Quality calibration records

• Review exception documents

• Review vendor certifications per applicable specifications

Cross Functional Duties

• Perform audits and assessments to assure compliance with regulatory requirements

• Serve as SME

• Perform air filter integrity testing

• Work with scheduling, production, quality and sterilization departments

• Work with Corporate Sterility Assurance and Metrology

What you'll bring

• Associate Degree with specialization in technical area, such as, metrology, instrumentation, electronics, mathematics, science or statistics.

• Completion of Quality Technician Basic Skills Training with demonstrated experience in the areas of metrology and instrumentation calibrations. Good math skills. Experience is statistical and data analysis techniques.

• Two years preferred proven experience with problem solving and analysis in the evaluation of test data and determination of data acceptability or validation of critical systems or equipment with responsibility for preparing test equipment and documentation, and identifying potential problems during validation studies.

• Electrical/Electronic experience in maintaining, testing and repairing electrical/electronic, mechanical, hydraulic and pneumatic systems and components.

• Two to three years of experience in a Quality role in a FDA regulated industry.

• Experience in computer systems to include MMS11 (Materials Management System) and GSQ (Global Supplier Quality) preferred.

• Technical writing skills.

• Proficient in: AS400, Trackwise, Maximo, Excel, Word and PowerPoint.

• Works in difficult position with walking, reaching, bending, pushing, rolling, pulling and/or stretching efforts are a part of the job. Manual dexterity and visual acuity are required. Hand/eye/foot coordination may be necessary as well.

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 $48,000 - $66,000 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. 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.

Other Duties as Assigned

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Overtime is worked as required.

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

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

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.

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