Specialist, Quality
3 settimane fa
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 organization's inspirational vision to be a global force in advancing dental performance through Best-In-Practice dentistry that improves lives around the world.
Position Summary The Quality Specialist is responsible for assisting in the administration of the quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR, and other applicable regulatory standards. This role coordinates document control transactions, site record retention, calibration, and inspection activities. In addition, the Quality Specialist will facilitate customer complaint investigations, assist in audit coordination, support supplier quality and customer assessments, and support risk management activities where appropriate. This role may also track and trend Quality data and support the site Management Review process.
Duties Complete document control transactions. Manage customer complaint investigations and complete complaint documentation. Facilitate CAPA and NCR investigations and may coordinate investigation documentation. Review DHRs and support batch record release. Manage record retention practices within the site. Manage site calibration activities and recordkeeping. Support site inspection activities and recordkeeping. Coordinate internal and external audits. Support supplier quality and customer assessment activities. Track and trend site Quality data. Support targeted Lean activities. Complete other duties as assigned. Education Degree Bachelor's Degree in Science or Engineering.
General Required Experience Two (2) years experience in a regulated industry (i.e. FDA/ISO 13485). Customer Focused: Demonstrates a "Customer first" mindset. Responds with a sense of urgency. Teamwork: Collaborates with others. Works in a professional manner to support team actions. Results: Effectively manages work tasks. Is detail oriented and strives for continuous improvement. Ability to analyze technical issues. Ability to cope with change and shifting priorities. Communication: Constructs clear written communication. Keeps manager and co-workers informed. Job Knowledge: PC experience and working familiarity of common desktop applications including Excel and Word.
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