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Job Title:  Specialist, Quality

Req ID:  29093
Job Category:  Quality

Fidenza, PR, IT, 43036

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

For Omnia, part of STERIS Group, we are looking for a QA Specialist to join our team in Fidenza!

PURPOSE:

Provide quality assurance support to Manufacturing Operations by resolving quality related issues, improving product quality and investigating customer complaints.

Utilize the Correction and Preventive Action system to pursue continuous improvement of the Quality System and Omnia products. Prepare and maintain accurate audit working papers and files to support audit findings.

Duties

• Manage NC’s process (including support to management of raw materials/components issues raised in Incoming and Production areas).

• Support CAPA’s process and follow-up on corrective actions to ensure that they are implemented on time and are effective.

• Ensure product complaints are promptly investigated and, where needed, adequate corrective/preventive actions are accordingly raised and implemented.

• Participation on demand in preparation of PFMEAs.

• Evaluate opportunities for improvements to the operation of the QA department.

• Support periodic review of department internal control procedures.

• Where necessary, gather and trend quality data for periodic review and Quality Management Reviews.

• Support the QA Supervisor for internal and external audits activities.

• Assist the QA Supervisor in developing the corrective action plans for any findings resulting from internal and external audits.

• Ensure that personal training records are maintained in conjunction with HR department.

Education Degree

Master's Degree in Chemistry or Pharmacy

Required Experience

• Master degree in Chemistry or Pharmacy, Chemistry and Pharmaceutical Technology (CTF).

• Knowledge and application of: ISO 13485, Medical Devices Directive (DDM) 93/42 / EEC, applicable standards required by the European and non-European market, CMDR SOR / 98- 282.

• Minimum knowledge of single-use medical devices

• Experience in audit activities.

• Good interpersonal and professional communication skills.

• Minimum of one to three years related experience required.

• Ability to work from designated office for collaborative/interactive fulfillment of duties.

• Flexibility and resilience.

 

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Duties - cont'd

 

STERIS is a leading provider of products and services that meet the needs of growth areas within Healthcare: procedures, devices, vaccines and biologics.  We exist to fulfill our MISSION TO HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD. STERIS is a $3B, publicly traded (NYSE: STE) company with approximately 16,000 associates and Customers in more than 100 countries.

STERIS strives to be an Equal Opportunity Employer.  

Req ID:  29093
Job Category:  Quality

Fidenza, PR, IT, 43036


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