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 resul t 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 organization’s inspirational vision to be a global force in advancing dental performance through Best-In-Practice dentistry that improves lives around the world.
Purpose:
Provide quality assurance support to Manufacturing Operations by resolving quality related issues, improving product quality and investigating customer compla
ints.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 find
ings.Support in the management of the QMS and PV activities according to the requirements for the pharmaceutical products.
ESSENTIAL DUTIES AND RESPONSABILITIES:
* Support in the management of the QMS and PV for the pharmaceutical
* products.Support NC’s process for products (including support to management of raw materials/components issues raised in Incoming and Productio
* n areas).Support CAPA’s process and follow-up on corrective actions to ensure that they are implemented on time and are e
* ffective.Ensure product complaints are promptly investigated and, where needed, adequate corrective/preventive actions are accordingly raised and imp
* lemented.Participation on demand in preparation o
* f pFMEAs.Evaluate opportunities for improvements to the operation of the QA de
* partment.Support periodic review of department pr
* ocedures.Where necessary, gather and trend quality data for periodic review and Quality Management
* Reviews.Support the QA Supervisor for internal and external audits ac
* tivities.Assist the QA Supervisor in developing the corrective action plans for any findings resulting from internal and externa
* l 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 Tec
* hnology (CTF).Knowledge of the requirements applicable to the pharmaceutical products, in part
* icular for PV.Knowledge of ISO 13485, Medical Devices Directi
* ve/Regulation.Experience in aud
* it activities.Good interpersonal and professional communi
* cation skills.Minimum of one to three years related experi
* ence required.Ability to work from designated office for collaborative/interactive fulfillm
* ent of duties.Flexibility and resilience in the face of constraints, frustrations
* or adversity.Appropriately and directly interact with other staff members and/or outsi
* de associates.Attend and participate in meetings via phone, computer or in person.