Overview
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At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.
Responsibilities
* Plan and execute activities concerned with the development, implementation, maintenance, and continuous improvement of STERIS quality systems. Use statistical techniques and other quality principles to support complaint/CAPA investigations, supplier quality improvement, and develop and maintain metric systems.
* Act as the Quality lead and interface externally and internally with customers to define requirements, communicate progress, identify solutions to quality issues, and demonstrate applied knowledge.
* Manage and communicate the status of Quality projects: prepare project plans, determine timelines and resources, and present information to cross-functional teams and management.
* Ensure management of changes associated with products and processes using science and risk-based assessment to determine impact.
* Assist in ensuring that current compliance issues and trends are evaluated and training is provided where appropriate.
* Analyze and maintain metric systems to provide feedback on Quality performance.
* Work with departmental managers to evaluate training needs and support effective learning interventions to ensure critical training requirements are provided to support compliance.
* Coordinate internal audit schedules and liaise with technical management to ensure corrective actions are executed timely and that quality meets required international standards as outlined in the Quality Manual.
* Support the site in process improvements and technical developments to increase operational efficiencies and maximize output.
Continued Duties
* Initiate and drive Continuous Improvement programs, monitor quality levels, identify root causes of quality problems, and take ownership of quality issues.
* Stay up to date with policy requirements, including change notification requirements.
* Ensure vendor appraisal, validation, calibration, and maintenance activities are effective and documented in a compliant manner. Support all external audits, regulators, agencies, and customers as required.
* Collaborate with other departments to provide and drive quality inputs into overall operational activities.
* Ensure compliance with safety procedures at all times.
* Internal Auditor experience – minimum one year of internal and lead auditor experience.
Education
* High School Diploma or GED
* Bachelor's Degree
Required Experience
* Strong understanding of QMS, NC/CAPA elements
* Experience working within a regulated industry – minimum two years
* Ability to interact and influence at all levels within the organization
* Ability to manage and deliver multiple projects effectively
* Demonstrated ability to facilitate or manage projects in a self-directed and dynamic manner
* Ability to work with various levels of the organization to ensure quality requirements are achieved
Skills
* Strong problem-solving ability
* Good communicator both verbally and in writing
* High attention to detail and accuracy
* Strong organizational skills
* Good interpersonal skills
STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare and life sciences products and services around the globe. For more information, visit www.steris.com.
STERIS strives to be an Equal Opportunity Employer.
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