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Quality Specialist (12 hour nights)

Company: Baxter
Location: Valdese
Posted on: August 6, 2022

Job Description:

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. Youll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.Baxters 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.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.1. 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 requests2. 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 specifications3. 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 MetrologyRequired Qualifications- Associate Degree with specialization in technical area, such as, metrology, instrumentation, electronics, mathematics, science or statistics OR 2 years of relevant experience.- Basic Skills Training with demonstrated experience in the areas of project management, validation and testing.- Must be at least 18 years of age- Must have basic English written and oral communication skills adequate to communicate with other team members- Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings- Must be able to perform advanced level mathematicsPreferred Qualifications- Experience (minimum experience will be considered in lieu of education listed above) Two (2) years preferably with metrology, calibration, or maintenance- 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.- Process improvement experience in developing test plans, testing and completing technical reports.-Technical writing skills-Proficient in: AS400, Trackwise, Maximo, Excel, word and Power PointOther Qualification and Physical Requirements:1. Candidates will be selected for interview based on the criteria contained in the quality specialist application package. The interview team will select the best candidate for the position out of the pool of candidates.2. Works in difficult position with walking, reaching, bending, pushing, pulling, and/or stretching efforts a part of the job. Manual dexterity and visual acuity required. Good eye/hand/foot coordination could be necessary as well.#IND-USOPS#LI-LF1The 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 OpportunityBaxter 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. Reasonable AccommodationsBaxter 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 here and let us know the nature of your request along with your contact information.Recruitment Fraud NoticeBaxter 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 . 052244by Jobble

Keywords: Baxter, Gastonia , Quality Specialist (12 hour nights), Other , Valdese, North Carolina

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