Senior Quality Technician

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

The Senior Quality Technician is responsible for assisting in administration of the quality management system at a site to assure adherence to ISO 9001, ISO 13485, FDA 21 CFR Part 820/211, EU GMPs, ISO 17025, ISO 11137 and/or ISO 11135 and other applicable regulatory standards. The Senior Quality Technician supports production and quality operations by coordinating and performing problem-solving investigations, pre-reviews and final acceptance/run release. Senior Quality Technicians open and lead investigations of process non-conformances, Customer complaints, CAPAs, internal/external audit findings and assist in the implementation of improvements. This role can also lead issue resolution with testing equipment and ODMS, as well as, understand and execute tests associated with dosimeter reading equipment, dosimeter calibrations and dosimeter batch acceptance. In addition, Senior Quality Technicians track, trend and analyze quality data and can delegate for the Quality Analyst/Manager when not available, including approval of Customer specification changes and direct Customer communications (i.e. off-shift or weekends).

Duties

•    Coordinate and conduct releases of processing runs after product has been processed, ensuring all processing parameters and Customer specifications have been met and the run file (device history record) is accurate and complete. 
•    In Lab facilities, coordinate and conduct review and release laboratory reports, ensuring tests comply with requirements and Customer requests. 
•    Executes Customer specification updates and direct Customer communications when delegating for the Quality Analyst/Quality Manager.
•    Leads investigations into Customer complaints and internal/external audit observations.
•    Assists in the development of new quality system policies and procedures, as well as,
•    identify and manage revisions to existing quality system policies and procedures.
•    Leads issue resolution with testing equipment and system functionality.
•    Assists in execution of quality system programs (i.e calibration management, training
•    administration).
•    Execute tests related to system equipment (i.e. spectrophotometer, micrometer, reference filters, etc). Perform ceric cerous measurements to approve dosimetry calibration curves during facility qualification following source loading. Responsible to escalate matters of non-compliance to site Quality Lead/Manager.
•    Overall responsibilities include commitment to ensure external and internal requirements
•    are met according to documented policies, procedures, standards and regulations.
•    Complete other duties as assigned.

Required Experience

•    Minimum of five (5) years of experience in manufacturing or processing environment or other technical/scientific field. Associate’s Degree in a related scientific/technical field required. Will accept minimum seven (7) years of experience in lieu of a degree.
•    Ability to work in a fast-paced, regulated environment with strict deadlines
•    Mathematical skills including ratios, proportions, basic algebra 
•    Ability to generate detailed, high quality documentation. 
•    Ability to analyze data, construct trends, pareto analyses and develop countermeasures
•    Ability to work with others in analyzing and solving technical problems.
•    Collaborates with others. Works in a professional manner to support team actions. 
•    Effectively manages work tasks. Is detail oriented and strives for continuous improvement.
•    Above average organizational skills
•    PC experience and working familiarity of common desktop applications including Excel and Word.

Pay range for this opportunity is $20.84 - $26.97.  This position is eligible for bonus participation.

Minimum pay rates offered will comply with county/city minimums, if higher than range listed.  Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc.

STERIS offers a comprehensive and competitive benefits portfolio.  Click here for a complete list of benefits: STERIS Benefits

Open until position is filled.

STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare and life sciences products and services around the globe. For more information