Role Overview
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.
Responsibilities
* 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.
Qualifications
* 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