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Quality Specialist
Summary
Title:Quality Specialist
ID:1218
Job Location:Grafton, WI
Description
Company Overview
Young Innovations is a manufacturer of high quality dental equipment and supplies with sales in excess of $120 million. With an outstanding reputation for quality, our company has a broad portfolio of market leading products across a variety of categories.

Role Overview
The Quality Specialist will provide support to the manufacturing process within a team orientated, customer-driven organization. This position will provide quality technical support to the facility related to corrective actions, process control, statistical analysis, component validation, product measurement and testing, product launch, product certification and audits. 

Responsibilities
  • Customer Complaints/Feedback: Trend, Investigate, and work with customer service, operations and/or engineering to resolve identified issues
  • CAPA: Assist with the planning, implementation, and effectiveness verification of corrective and preventive actions
  • Non-Conformances: Assist production with the investigation of component an finished good non-conformances. Assist supplier management and Quality Control wit the investigation of sourced raw materials, components, and finished goods
  • Deviations: Monitor and investigate deviations 
  • Investigations: Use Quality tools to determine root causes of identified issues
  • Continuous improvement of quality systems: Review systems, procedures, & executed records to determine gaps and to identify areas for improvement
  • Change management: Assist in the management of the change control system. Review proposed changes and help identify related, impacted processes/procedures/materials/etc.
  • Training: Identify training requirements, identify gaps, and report on overall compliance. Assist with annual and ad hoc GMP training
  • Generation & maintenance of Device Master Records and Device History Files
  • Generation & maintenance of material specifications: raw materials, components, & finished product
  • Assists with generation, execution, and review of qualification/validation protocols
  • Perform risk assessments (FMEA, etc) and initiate action plans
  • All other duties as assigned
Qualifications

Training and Experience
  • A bachelor of science degree or 4 years or more of QA/QC/RA experience in a FDA-regulated industry
  • Working knowledge of quality systems (21 CFR 820) 5 years or more experience in an FDA regulated environment preferably in a manufacturing facility  
  • Excellent verbal and written communications
  • Analytically assess data to determine trends and root causes
  • Ability to organize, prioritizes, and perform multiple tasks with minimal supervision
  • A sense of urgency, good attention to detail, and follow-thru
  • Working knowledge of Microsoft Word, Excel, Power Point and Adobe Acrobat
 
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Young Innovations is an equal opportunity employer and recruits, hires, trains and promotes persons in all job titles without regard to race, color, religion, sex, national origin, age, citizenship, disability or veteran status.