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.
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.
- 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.
- 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.
- 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.
- Based on established procedures, assists with the review and maintenance of calibration records to ensure calibration is performed properly and in a timely manner.
- Assists in the establishment of appropriate policies and procedures, as well as revision and maintenance of the My Isomedix System.
- Assists with writing deviations and documenting Customer concerns based on established Customer specifications and QS/RC policies and procedures.
- 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.
- With direction from the QS/RC Manager, prepares the monthly internal assessment report.
- 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.
- Contributes to maintaining a safe and clean working environment by performing routine area housekeeping and reporting any unsafe conditions to facility management.
- 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.
Contributes in a team effort by performing according to the guidelines outlined in the STERIS Code of Business Conduct, the GMP, Lean principles and other directives; supports the directives and decisions of higher level management and performs other duties as assigned.
Minimum of 1 year of related experience.
- Ability to effectively read, write and verbally communicate in English.
- Ability to work independently under general guidelines and supervision.
- Requires computer literacy to include word processing, spreadsheet and software capabilities.
- Requires effective interpersonal skills as demonstrated through prior experience.
- 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.
- Able to adapt to changing duties and responsibilities.
- Normal hearing range sufficient to hear alarms, bells, horns, etc.
STERIS is a $2B+, publicly traded (NYSE: STE) organization with approximately 12,000 associates worldwide and operates in more than 100 countries.
If you need assistance completing the application process, please call 1 (440) 392.7047. This contact information is for accommodation inquiries only and cannot be used to check application status.
STERIS 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.