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Quality Specialist
Grafton, WI
Job Description
Role OverviewThe 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.ResponsibilitiesManages 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. QualificationsA bachelor of science degree or 4 years or more of GMP experience in a FDA-regulated industryKnowledge of medical device quality systems (21 CFR 820, ISO 13485) 5 years or more experience in an FDA regulated environment preferably in a manufacturing facilityExcellent verbal and written communicationsAbility to organize, prioritizes, and perform multiple tasks with minimal supervisionAbility to work collaboratively with others to solve problemsWorks with a sense of urgency, good attention to detail, and follow-thruExtensive experience using Microsoft Word, Excel, Power Point and Adobe Acrobat. Young Innovations, Inc. is an Equal Opportunity Employer and E-Verify participating employer
Job Summary
Company
Young Innovations
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
4+ years
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