Requirements: English
Company: HuFriedyGroup
Region: emilia romagna, italy , Emilia-Romagna
Join Our Team at HuFriedyGroup Innovating Excellence in Dental Instrument Manufacturing
HuFriedyGroup is a leading manufacturer of dental instruments and infection prevention products. Our 10,000-plus products, hand-crafted by highly skilled artisans, are known for their precision, performance, longevity, reliability, and quality. To help dental professionals be The Best in Practice, HuFriedyGroup provides a unique combination of world class products, value-added services, clinical education, and dental community platforms that result in superior clinician performance and enhanced safety for dental professionals and their patients. Working at HuFriedyGroup is so much more than a job, as every employee has a part in driving and supporting the organizations inspirational vision to be a global force in advancing dental performance through Best-In-Practice dentistry that improves lives around the world.
JOB 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.
ESSENTIAL DUTIES AND RESPONSABILITIES:
- Manage NCs process for Chemistry products and Disposable machines (including support to management of raw materials/components issues raised in Incoming and Production areas).
- Support CAPAs 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.
QUALIFICATION REQUIRED FOR POSITION:
- 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 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.
- Attend and participate in meetings via phone, computer, or in person.
EMPLOYMENT TYPE: