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

Aquí es donde salvas y sostienes vidas

En Baxter, estamos profundamente conectados por nuestra misión. No importa tu rol en Baxter, tu trabajo tiene un impacto positivo en la gente alrededor del mundo. Sentirá un propósito en toda la organización, ya que sabemos que nuestro trabajo mejora los resultados para millones de pacientes.

Los productos y terapias de Baxter se encuentran en casi cada hospital del mundo, el clínicas y en los hogares. Por más de 85 años hemos sido pioneros en innovaciones médicas significativas que transforman el cuidado en salud.

Juntos creamos un lugar donde somos felices, exitosos y nos inspiramos mutuamente. Aquí es donde puedes hacer tu mejor trabajo.

Únete a nosotros en la intersección de salvar y sostener vidas-donde tu propósito acelera nuestra misión.

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.