Quality Specialist
About The Position
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. About this role The Quality Specialist is responsible for assisting in 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 may: own document and master data control transactions, site record retention, calibration and inspection activities, 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.
Requirements
- Associates degree in engineering or related feild + Two (2) years of experience in Quality in a regulated industry (i.e. FDA/ISO 13485)
- Four (4) years of experience in Quality in a regulated industry (i.e. FDA/ISO 13485) with a high school diploma or equivalent.
- 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 and support projects with cross-functional teams. 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 proficiency in common desktop applications including Excel and Word. May include ERP system management, use of an electronic quality management system
Responsibilities
- Complete document and master data control transactions.
- Perform customer complaint investigations and complete complaint documentation.
- Facilitate CAPA and NCR investigations and may coordinate investigation documentation.
- Review DHR’s and support batch record release.
- Manage record retention practices within the site.
- Manage site calibration program.
- Support site inspection activities and recordkeeping.
- Support internal and external audits.
- Support supplier quality assessment activities.
- Complete document and master data control transactions
- Perform customer complaint investigations and complete complaint documentation
- Facilitate CAPA and NCR investigations and may coordinate investigation documentation.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
