Job Title:  Quality Specialist

Position Summary

We are looking for a Quality Specialist to join our team based in Fidenza. He/she will Provide quality assurance support to Manufacturing Operations by resolving quality related issues, improving product quality and investigating customer complaints. 

He/she will 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 for Chemistry products and Disposable machines (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

Required Experience

• 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.
• Minimum of one to three years related experience required.

Other Information

• Good interpersonal and professional communication skills.
• Ability to work from designated office for collaborative/interactive fulfillment of duties.
• Flexibility and resilience in the face of constraints, frustrations or adversity.
• Appropriately and directly interact with other staff members and/or outside associates.
• Operate office equipment such as computer and telephone.
• Our offer consists of a 12 months fixed term contract

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.