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Quality Specialist (6th Shift: 7pm-7am)


This is a Full-time position in Marion, NC posted January 25, 2023.

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

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.

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.