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QS & RC Technician I

QS/RC Technician I
Our Mission: At STERIS plc, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.
Who we are: STERIS is a growing provider of infection prevention and other procedural products and services through our family of wholly owned subsidiaries, including: IMS, US Endoscopy, Albert Browne Limited, Eschmann Holdings Limited and Synergy Health Limited, among others.
Summary
Assists Quality System/Regulatory Compliance (QS/RC) and Analyst(s) to ensure external and internal Customer requirements are met according to documented and communicated policies and procedures.
Essential Job Functions
1. Based on established procedures, is responsible for the review and approval of processing files prior to product processing. The review ensures accurate product codes for numbers, case count, and cycle specifications.
2. Based on established procedures, is responsible for the review of processing files after product processing, and prior to product release, in order to ensure processing parameters have been met.
3. Assists with the review of operating logs (spectrophotometer, gamma dose computational software log, pre-conditioning, aeration and maintenance) to ensure timely and accurate record keeping processes.
4. Based on established procedures, assists with the review and maintenance of calibration records to ensure calibration is performed properly and in a timely manner.
5. Assists in the establishment of appropriate policies and procedures, as well as revision and maintenance of the My Isomedix System.
6. Assists with writing deviations and documenting Customer concerns based on established Customer specifications and QS/RC policies and procedures.
7. With direction from the QS/RC Manager or Analyst, assists with corrective actions as required by process deviations, procedure deviations, complaints, regulatory audits, Customer audits, and internal audits.
8. With direction from the QS/RC Manager, prepares the monthly internal assessment report.
9. Contributes in a team effort by performing according to the guidelines outlined in the STERIS Code of Business Conduct, the GMP and other directives; supporting the directives and decisions of higher level management; accomplishing other duties as assigned.
10. Contributes to maintaining a safe and clean working environment by performing routine area housekeeping and reporting any unsafe conditions to facility management.
11. Supports the STERIS AST business imperatives of Business Growth, Operational Excellence, Leadership Excellence and Customer Focus, by acting with integrity, treating everyone with mutual respect, exhibiting a genuine commitment to the success of all employees, and delivering satisfaction to our Customers through teamwork, innovation and continuous improvement; this will be accomplished while acting safely and is defined as "The STERIS Way."
12. Exhibits a commitment to the STERIS 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.
Job Requirements
Education/License Requirements
Associate's Degree or equivalent training and experience.
Experience Requirements (Skills, Knowledge and Abilities)
Requires:
1. One or two (1-2) years performing Quality Technician level responsibilities and/or one to two (1-2) years of sterilization experience.
2. Ability to effectively read, write and verbally communicate in English.
3. Ability to work independently under general guidelines and supervision.
4. Computer skills and work processing, spreadsheet and software capabilities.
5. Above average organizing, analyzing and a minimum of Level 3 math skills (ratios, proportions basic algebra) to determine organizational Customer and regulatory problems to formulate corrective action plans.
6. Ability to adapt to changing duties and responsibilities.
7. Requires effective interpersonal skills as demonstrated through prior experience.
8. Normal hearing range sufficient to hear alarms, bells, horns, etc.
Working Conditions
Position requires sitting, walking, bending, stooping, climbing, grasping, and talking in a processing and office environment. Nature of work requires depth perception, close and far vision, normal color distinction, potential for eyestrain and normal finger dexterity. The work environment includes working in proximity to contained controlled ionizing radiation and/or controlled and contained toxic flammable gas (ethylene oxide) and other treatment/process chemicals of which further information is available through the facility's Hazardous Communication Standard (Right to Know). There is potential for exposure to sub-protection levels of noise, heat and humidity. Hours of work exceed normal business hours. Will require use of personal protection items as needed. May require occasional day and overnight trips.
STERIS plc is a $2B+, publicly traded (NYSE: STE) organization with more than 14,000 employees worldwide. We are dedicated to providing our Customers with innovative infection prevention, decontamination, and health science technologies, products and services.
Visit https://www.steris.com/about/careers/ to learn more.
STERIS plc is an Equal Opportunity Employer. We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.
We assure you that your opportunity for employment depends solely on your qualifications. Those applicants requiring reasonable accommodation(s) to complete this application and/or during the interview process should notify a representative of the Human Resources department at 440-392-7047.
Career Level
Entry-Level
Education
High School or Equivalent
Travel
0 - 10%
Category
Quality
Shift Type
Second Shift

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