Cardinal Health Sr Engr, Quality (Sterility Assurance) in Waukegan, Illinois
What Quality Engineering contributes to Cardinal Health
Quality Engineering is responsible for product and service quality planning, evaluation and control. Works cross-functionally in the development and implementation of prevention based methodologies used in design, manufacturer, test, sustainability and correction of products and services.
- Demonstrates understanding of quality philosophies, principles, systems, methods, tools, and standards.
- Demonstrates understanding of the audit process including types of audits, planning, preparation, execution, reporting results and follow-up.
- Develops and implements quality programs, including tracking, analyzing, reporting and problem solving.
- Plans, controls, and assures product and process quality in accordance with quality principles, which include planning processes, design control, material control, acceptance sampling and measurement systems.
- Demonstrates knowledge of reliability, maintainability, and risk management, including key terms and definitions, modeling, systems design, assessment tools and reporting.
- Applies problem solving and quality improvement tools and techniques, including, preventative and corrective actions and how to overcome barriers to quality improvements.
- Acquires and analyzes data using appropriate standard quantitative methods to facilitate process analysis and improvements.
Support review of sterilization batch records and the release of Ethylene Oxide (EO) and gamma radiation sterilized loads.
Function as primary back-up to sterilization load release team
- Responsible for the supplier management of contract sterilizers and sterility testing support laboratories.
- Responsible for the deviation investigation and management of contract EO and gamma sterilizers and sterility testing support laboratories. Perform technical evaluations of abnormalities in sterilization processing and batch records for product release.
- Support and perform supplier audits including contract sterilizers and sterility testing support laboratories.
- Support regulatory compliance audits.
Responsible for coordinating activities associated with sterilization process R&D, optimization, and validation, as assigned.
Support of EO sterilization process annual requalification’s, annual reviews, and quarterly gamma dose audit testing according to ANSI/AAMI/ISO standards.
- Perform sterilization process development, chamber qualification/validation, equivalency, parametric release statistical evaluations/process maintenance and implementation activities across contract sterilizers.
- Technical Writing including authoring of study protocols/final reports and data analysis/ verification.
- Responsible for project management and coordination of activities associated with special projects (complaint investigation, regulatory compliance, cost savings, etc.), and cross functional teams as assigned.
- Authoring and maintenance of procedure, policy, and form updates within quality system.
- Support and management of Sterility Assurance programs such as Environmental Monitoring, Bioburden Monitoring, Product Adoption, and Sterilization Metrics
- Minimum Bachelor’s degree in microbiology, biology, or engineering preferred, or other related scientific field
- >3 years professional experience within an FDA regulated industry, preferably medical devices preferred
- >3 years working experience in a quality or regulatory role preferred
- >2 years working experience in a sterilization or sterility assurance engineering related role
- Microbiology lab background experience is preferred but not required.
- Must be proficient in MS Office applications and with strong project management and communication skills including scientific technical writing.
What is expected of you and others at this level
- Applies working knowledge in the application of concepts, principles, and technical capabilities to perform varied tasks
- Works on projects of moderate scope and complexity
- Identifies possible solutions to a variety of technical problems and takes actions to resolve
- Applies judgment within defined parameters
- Receives general guidance may receive more detailed instruction on new projects
- Work reviewed for sound reasoning and accuracy
Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.
Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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