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Title:  QS & RC Technician II

Req ID:  14404
Category:  Quality
City:  Chester
State:  NY
Postal Code:  10918
Description: 

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.

Position 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.

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Duties

  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. Conducts QS/RC review and approval of Emergency Customer Specification changes required to process product e.g. during facility off-shift where QS/RC Analyst/Manager position is not available.
  4. Assists in resolving any issues with Dosimetry testing equipment and ODMS-RT functionality at the facility level and under QS/RC ODMS-RT permission control level primarily during staggered shifts (2nd and weekends).
  5. Assists with the review of operating logs (spectrophotometer, gamma dose computational software log, preconditioning, aeration and maintenance) to ensure timely and accurate record keeping processes.
  6. Understands and executes tests related to the required control of the Dosimetry System Equipment (Computer, Spectrophotometers, Laser Micrometers, Reference filters, etc.) for example, daily and/or weekly tests as required by the approved procedures.
  7. Based on established procedures, assists with the review and maintenance of calibration records to ensure calibration is performed properly and in a timely manner.
  8. Assists/performs Ceric Cerous Measurements (as per certification) to approve Dosimetry Calibration Curves (e.g. during facility Qualification).
  9. Assists in the establishment of appropriate policies and procedures, as well as revision of same.
  10. Assists with writing deviations and documenting Customer concerns based on established Customer specifications and QS/RC policies and procedures.
  11. Communicates directly with Customers on behalf of QS/RC when Management/Analyst is not available (e.g. Escort Customers on-site for special handling/inspection per Customer requirements requiring QS/RC Representation).
  12. 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.
  13. With direction from the QS/RC Manager, prepares the monthly internal assessment report.
  14. Contributes to maintaining a safe and clean working environment by performing routine area housekeeping and reporting any unsafe conditions to facility management.
  15. 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.
  16. 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.

Education Degree

  • Associate's Degree

Required Experience

  1. One to two 2 years performing Quality Technician level responsibilities and/or three to five (3-5) years of sterilization experience.
  2. Ability to effectively read, write and verbally communicate.
  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.
  6. Requires effective interpersonal skills as demonstrated through prior experience.
  7. 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.

Req ID:  14404
Category:  Quality
City:  Chester
State:  NY
Postal Code:  10918


Nearest Major Market: Middletown
Nearest Secondary Market: Poughkeepsie

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