|Job Location:||Grafton, WI|
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.
The Quality Specialist will provide support to the manufacturing process within a team orientated, customer-driven organization. This position will provide quality system and GMP support to the facility related to corrective actions/CAPA, change management, management reviews, customer complaints, training, document and records management, nonconformance’s, and audits.
- Manages the site document management and change control processes, coordinates reviews both on site, with customers, and suppliers. Updates documents as required and performs bi-annual document reviews.
- Coordinates the site Nonconformance and MRB processes. Assist with the planning, implementation, and effectiveness verification of corrective and preventive actions.
- Assists production with the investigation of component and finished good non-conformances.
- Coordinates the receipt, investigation and response to customer complaints.
- With Manager, coordinates the site Quality System management reviews and associated activities.
- Coordinates and reports on key quality metrics and reports. Analytically assess data to determine trends and root causes.
- Reviews systems procedures, and executed records to determine gaps and to identify areas for improvement.
- Administer the sites training program and training records. Prepares training materials and performs on-site training on relevant GMP topics for staff and new hires.
- Generates and maintains Device Master Records, Quality System Records and Device History Files.
- With Manager coordinates on-site customer, internal and ISO 13485 audits. Organizes any corrective and preventive actions that are an outcome of audits.
- Maintains all relevant GMP files in compliance with applicable regulatory and record retention requirements.
- Oversees the quality system requirements, testing and release of externally produced nasal swabs.
- Participates in site continuous improvement efforts and initiatives.
- A bachelor of science degree or 4 years or more of GMP experience in a FDA-regulated industry
- Knowledge of medical device quality systems (21 CFR 820, ISO 13485) 5 years or more experience in an FDA regulated environment preferably in a manufacturing facility
- Excellent verbal and written communications
- Ability to organize, prioritizes, and perform multiple tasks with minimal supervision
- Ability to work collaboratively with others to solve problems
- Works with a sense of urgency, good attention to detail, and follow-thru
- Extensive experience using Microsoft Word, Excel, Power Point and Adobe Acrobat.
Young Innovations, Inc. is an Equal Opportunity Employer and E-Verify participating employer