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

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 reports that are sent 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 and evaluate studies per specification or protocol, Identify out of specification/protocol conditions, Analyze data, materials and/or equipment to determine the cause of out of limits or exception conditions and issue exception reports. Prepare study package for management review and approval, Review/approve sterilization maintenance requests. Metrology: Conduct calibrations of critical gauges, meters and being responsible for 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 along with 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 or equivalent experience 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.