Job Title:  Senior Quality Inspector

Position Summary

STERIS is seeking a Senior Quality Inspector to join the team! The Senior Quality Inspector is responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards. The Senior Quality Inspector supports manufacturing and servicing operations by performing incoming component and in-process product inspections which are more complex requiring the use of sophisticated measurement systems and instrumentation.  Senior Quality Inspectors identify and document component, process and product non-conformances and lead investigation/root-cause countermeasure activities. They work with operations team members to perform and document problem-solving investigations.  In addition, Senior Quality Inspectors may oversee device history record reviews and manage calibration and environmental monitoring processes.

Duties

1. Conducts complex incoming component and in-process product inspections.
2. Participates in quality investigations and associated problem-solving / root-cause activities.
3. Supports the creation of incoming inspection plans.
4. Identifies and documents product and process non-conformances.
5. Identifies opportunities for process continuous improvement.
6. Participates on a Material Review Board to review and process non conformance reports.
7. May review DHR paperwork for completeness and accuracy against standards.
8. Tracks, trends and reports quality data for assigned areas.
9. May support site calibration activities depending on facility structure.
10. Complete other duties as assigned.

Education Degree

Required Experience

1. 3 or more years of experience in mechanical inspection or other technical production tasks. 

Skills

1. Ability to work in a fast-paced environment with strict deadlines
2. Ability to generate detailed, high-quality documentation.
3. Ability to work with others in analyzing and solving technical problems.
4. Ability to perform / manage multiple tasks in parallel.
5. Teamwork: Collaborates with others. Works in a professional manner to support team actions. 
6. Effectively manages work tasks.  Is detail oriented and strives for continuous improvement.
7. PC experience and working familiarity of common desktop applications including Excel and Word.