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Job Title:  Quality Engineer

Req ID:  17260
Job Category:  Quality
Country:  IE
State:  OY
City:  Tullamore
Zip:  R35
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

Responsible for the activities related to Quality Systems/Regulatory Compliance (QS/RC) Work Instructions to ensure all product processing requirements are met in accordance with Customer specifications including calibrations, generation of test methods, audits, scheduling, validations, record keeping, facility walk throughs and reporting as directed by the Operational Quality Manager. 

Duties
  •         Manages and provides deliverables for Work Instruction revisions, Management Reviews, Customer audits, Regulatory Audits, in house calibration efforts such as dosimetry calibrations and internal audits. (30%)
  •         Performs or facilitates the review of facility operating logs (dosimetry equipment, gamma dose computational software log, pre-conditioning, aeration, maintenance and other logs as defined by local Work Instructions), to ensure timely and accurate record keeping as well as to identify trends. (10%)
  •      Writes or assists in the writing of Non-conformances, Customer Complaints, CAPAs and responses to Audit Findings. (10%)
  •      Hosts Customer audits as assigned by the Operational Quality Manager 10% of Daily Duties.
  •      Under the direction of the Operational Quality Manger coordinates the calibration program to ensure that equipment is calibrated in an on time fashion. Looks for trends in calibrated equipment. (10%)
  •        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. (10%)
  •      Facilitates the establishment of appropriate policies, procedures, and Work Instructions as well as revision and maintenance of AST quality systems. (5%)
Duties - cont'd
  •        Develops vehicles and tools, and conducts analysis of relevant metrics to identify areas for continuous improvement. (5%)
  •        Monitors data and trends relative to the Quality system and makes recommendations for improvement as well as establishes implementation plans. (5%)
  •         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.
Education Degree
Bachelor's Degree
Required Experience
  • Number of years experience with degree indicated above and type: 3-7 years
  • Requires ability to effectively read, write and verbally communicate
  • Requires ability to work independently under general guidelines and supervision
  • Computer skills and work processing, spreadsheet and software capabilities.

 

STERIS plc is a $3B, publicly traded (NYSE: STE) organization with more than 12,000 employees worldwide.

STERIS strives to be an Equal Opportunity Employer.  


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