Quality Specialist (7:00pm-7:00am)

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.

Position Summary

Responsibilities fall into two main areas: 1) Sterilizer studies and 2) metrology. Assure that sterilization and calibration processes comply with Corporate and Plant requirements. Interface with manufacturing, maintenance and plant sterilization to assure equipment availability and production throughput. Provide data for inclusion in reports to regulatory agencies.

Sterilizer Studies

• Conduct qualification, requalification and evaluation studies
• Determine 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
• Interface 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
• Interface with scheduling, production, quality and sterilization departments
• Interface with Corporate Sterility Assurance and Metrology

Education Requirements

• 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.

Preferred Experience

• Two (2) years:
  • Proven 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.

Preferred Qualifications

• 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.

Physical Requirements

• 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 our employees, and we strive to be more transparent with our pay practices. To that end, this position has a salary range of $33,000 to $76,000. The above range represents the expected salary range for this position. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in the role, business line, and geographic/office location

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.

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 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.

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.