Quality Assurance assists in the design and implementation of policies and procedures for testing and evaluating the precision and accuracy of products and/or equipment. The Quality Assurance Coordinator will: Administer MRB and NCR processes within the Quality System to ensure timely disposition of product and
address issues and trends effectively and in compliance with regulatory requirements and standards. Support Quality System goals to achieve overall business
unit metrics. Provide Quality representation and support related to Quality System and production, supplier and customer product issues. Coordinate internal DHR review program and support training of operations personnel. Act in a professional and exemplary manner when conducting business with company employees, suppliers, and customers.
Administer the MRB (Material Review Board) and NCR (Non conformance Report) System.
Chair MRB process and oversee flow of product in and out of MRB.
Ensure timely disposition of nonconforming material, ensuring compliance to regulatory and customer requirements.
Generate periodic facility metrics related to NCR activities including SCRAP caused by NCRs.
Provide training to incoming, in process and final inspectors to ensure proper documentation of NCRs.
Support supplier management by providing data for incoming inspection rejections and issuing SCARs.
Provide support to Document Control, DHR Review, and other functions to help ensure departmental coverage.
Comply with all work rules including those pertaining to safety, health, quality and company's Quality Management System.
Perform other duties as necessary.
Excellent communication (both verbal and written), organizational and project management skills.
Demonstrated ability to implement and administer quality programs and interpret NCR data to drive continuous improvement.
Training or equivalent experience in computer use and software – Microsoft Word, Excel, Access and Power Point.
Skills in Microsoft Visio and Project a plus.
Typically a Technical degree (or equivalent college coursework toward a 4-year degree) plus two years experience in manufacturing, management, and/or an ISO quality systems role.
(High School diploma or equivalent requires four years experience in manufacturing, management, and/or an ISO quality systems role.)
Formal training in Quality-related fields and ASQ or similar certification as Quality Technician or Quality Auditor preferred.
Knowledgeable of FDA Quality System Regulations (21CFR Part 820) and ISO 13485 as applicable to manufacturing environments that produce components or devices for the medical industry
WOTC, tax credits, background checks, human resources