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Quality Assurance Manager
Summary
Title:Quality Assurance Manager
ID:1040
Job Location:Grafton, WI
Description

Company Overview
Microbrush International develops, produces, and markets innovative disposable applicators designed for the placement of controlled amounts of materials in hard-to-reach areas. Microbrush is a wholly owned subsidiary of Young Innovations, Inc. Young Innovations is a manufacturer and marketer of high quality dental equipment with sales in excess of $140 million.

 

Role Overview
We are looking for a driven Quality Assurance (QA) Manager to join the Microbush team at our Grafton, Wisconsin location. The QA Manager will be responsible for supporting the quality system to ensure it meets all established regulatory requirements and assuring that all products manufactured and sold meet the needs and expectations of customers via thorough administration of our Quality Assurance and Control activities, process improvement initiatives and product design activities. . The QA Manager reports to the Vice President of Quality/Regulator Affairs and will provide leadership, coaching, and direction to an on-site Quality Engineer and QA Inspection team.

 

Responsibilities

  • Serve as the site’s Management Representative during agency investigations, audits, and inspections; prepares required responses, corrective action report, and assures that effective corrective action is implemented
  • Manage the internal audit programs and coordinates external audits and inspections from government agencies, including closing observations
  • Initiate and implement quality improvement activities as appropriate to raise the quality and compliance of the site’s product line and processes, which includes educating and training employees on the Quality Management System
  • Establish and implement metrics (process capability, control charts, measurement quality) for monitoring system effectiveness and to enable managers to make sound product quality decisions; conduct Management Review in compliance to ISO and FDA requirements
  • Manage and maintain compliance with FDA Quality System Requirements;assist regulatory Affairs and Operations with product development, regulatory submissions and technical information for international registrations
  • Support the market-release of products as necessary, including review of labeling, promotional materials, product/manufacturing process changes and related Quality System documentation changes
  • Manage the Customer Complaint program and ensure investigations and corrective actions are timely and effectively implemented
  • Serve as the Coordinator of the quality control resources for problem identification, resolution, loss reporting and continuous improvements
  • Support engineering efforts by participating in product development projects, representing quality assurance and the customer
  • Design, implement and document procedures for process control, process improvement, testing and inspection; perform root-cause analysis and other problem solving activities to identify and implement effective corrective actions and process improvements
  • Hire, coach, develop, and provide daily supervision and leadership to Quality Assurance team

 

Qualifications

  • Bachelor of Science degree in a related field, supplemented by at least seven years of relevant experience with 2 years in leadership role in a manufacturing environment with demonstrated pattern of success
  • Prior experience participating and/or leading FDA audits
  • In depth knowledge of 21 CFR 210, 211, and 820
  • Understanding of classified manufacturing areas (i.e., Class 10,000 per Fed STD 209E or ISO Class 7)
  • Thorough knowledge of Good Manufacturing Practices, Lean Manufacturing disciplines, and continuous improvement
  • Strong knowledge of relevant regulatory guidance, including current Good Manufacturing Practices (cGMPs), FDA, EPA and ISO
  • Ability to read and understand published regulations
  • Excellent verbal and written communication skills to all levels of the organization
  • Excellent leadership skills to include interpersonal, coaching, and facilitation skills
  • Strong skills in applying statistical methodologies and problem-solving techniques
  • Skill in writing and editing technical documentation
  • Minimal travel required

 

Young Innovations/Microbrush International are an Equal Opportunity Employer and E-Verify participating employer

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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.