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.
Responsible for the activities related to Quality Systems / Regulatory Compliance (QS / RC) procedures to ensure all product processing requirements are met in accordance with Customer specifications including calibrations, generation of test methods, audits, scheduling, validations, record keeping and reporting as directed by the QS / RC Manager.
1. Periodically performs pre-review of processing files for new product or new specification requirements after product processing and prior to product release in order to ensure processing parameters have been met.
2. Performs or facilitates the review of operating logs (spectrophotometer, gamma dose computational software log, pre-conditioning), to ensure timely and accurate record keeping.
3. Performs or facilitates the review and maintenance of calibration records to ensure calibration is performed in a timely manner.
4. Establishes or facilitates the establishment of appropriate policies and procedures as well as revision and maintenance of AST quality systems.
5. Writes or assists in the writing of deviations and responses to deviations as well as documenting Customer concerns based on established Customer specifications and QS / RC policies and procedures.
6. Develops corrective actions as required by process deviations, procedure deviations, complaints, regulatory audits, Customer audits and internal audits, and develops training materials and trains employees in response to procedural changes, policy changes and improvement activities.
7. Prepares or facilitates the preparation of the monthly internal assessment report
8. Manages and provides deliverables or special projects such as procedure revisions. Develops vehicles and tools, and conducts analysis of relevant metrics to identify areas for continuous improvement.
9. Provides support in the forms of data, documentation and feedback for Customer and / or regulatory audits, as well as internal audits.
10. Monitors data and trends relative to the Quality system and makes recommendations for improvement as well as establishes implementation plans.
11. Maintains professional skills, knowledge and abilities by attending educational workshops, reviewing professional publications and participating in professional societies.
12. Communicates in an effective manner by utilizing accepted business practices in a courteous and professional manner providing timely and accurate responses and service oriented offers of assistance.
13. Exhibits a commitment to the AST shared values of Customer Satisfaction and Continuous Improvement through ensuring defect-free workmanship, assisting others to meet the Customer’s needs, searching for efficient and effective ways to reduce waste, being active and accountable for Customer satisfaction, and satisfying the Customer’s needs with a sense of urgency.
supports the directives and decisions of higher level management and performs other duties as assigned.
Requires a minimum of two to three (2-3) years of related experience.
2. Requires ability to effectively read, write and verbally communicate in English.
3. Requires ability to work independently under general guidelines and supervision.
4. Requires effective interpersonal skills as demonstrated through prior experience.
5. Computer skills and work processing, spreadsheet and software capabilities.
6. Requires above average organizing, analyzing and Level 4 math skills (practical application of fractions, percentages, ratios, proportions, measurements and basic algebra) to determine organizational Customer and regulatory problems and formulate corrective action plans; attention to detail.
7. Able to adapt to changing duties and responsibilities.
8. Able to influence people in the opinions, attitude or judgments; to generalize, evaluate and decide; to adapt to situations under stress.
9. Requires normal hearing range sufficient to hear alarms, bells, horns, etc; normal visual acuity.
STERIS is a leading provider of products and services that meet the needs of growth areas within Healthcare : procedures, devices, vaccines and biologics.
We exist to fulfill our MISSION TO HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD. STERIS is a $3B, publicly traded (NYSE : STE) company with approximately 16,000 associates and Customers in more than 100 countries.
STERIS strives to be an Equal Opportunity Employer.
outline : none !important; Req ID : 26766 Job Category : Quality
Coyol, A, CR, 20102