Job Title:  Quality Technician

Position Summary

We are looking for a Quality Technician to join our Quality team based in Seriate (BG). To implement the Quality Management System in Seriate eBeam site under the supervision of the Site QA Supervisor and in collaboration with QA Team Italy.

Duties

1.To review batch documentation after processing and to ensure that errors, problems and anomalies are fully investigated and documented.

2.To be responsible for conforming product release for all processes at site.

3.To ensure Quality System in Production is in compliance with STERIS Procedures, Standards and any Applicable Laws.

4. To initiate, investigate, control and analyze non-conformance reports, to ensure corrective action, in collaboration with all departments involved, is implemented and that it is effective.

5.To initiate, investigate, control and analyze the recording and investigating of Customer

6.To support the Site QA Supervisor and the QA Team, in conjunction with the technical groups, to verify the conformity of all process validation documents (PQ) and in collaboration with Validation Department and the Site QA Supervisor, to ensure the need for validation is identified and ensuring that the appropriate action is taken.

Duties - cont'd

7.To develop, support and maintain the Production Employee Training Program about Quality Guidelines.

8.To identify and report any failures in the implementation of the quality system to the Site QA Supervisor, Country Quality Manager ITA and Operations Management.

9.To support and facilitate Audits. Ensure that the internal audit program is executed as per plan and perform audits as required

10.To monitor Production and Quality performance periodically and provide a report to all Departments of Seriate site on a regularly scheduled basis; monitor day to day CAPA reporting to ensure timely closure.

11.To support the Site QA Supervisor and the QA Team to implement continuous improvement activities in agreement with the Plant Manager.

12.To control, ensure that each new Local Working Instruction drafted agrees with STERIS Policy and QMS, in collaboration with the Site QA Supervisor and the QA Team, Production and Tech Team; to assist all Departments in their application.

Education Degree

Required Experience and Competencies

Good level of English reading, writing and speaking communication skills

Full availability to travel

Preferable and appreciable knowledge in ISO 13485, ISO 11137, GMP and Quality Management

Team work attitude

Knowledge in Microsoft Office applications (Word, Excel, Access and Power Point).

Full time role, in case of needs, the person should be flexible in his/her time schedule

Additional Information

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,  sex, sexual orientation, gender identity, genetic information, and any other category protected by state or local law.