Senior Validation Quality Engineer

Business Title: 3075 | Senior Validation Quality Engineer Location: Sturtevant, WI 53177 Job Type: Contract (6 M+) Job Description: This position will provide validation, engineering and technical support for all facilities supporting Manufacturing and Distribution. It will coordinate and execute product and process validations as appropriate to the Quality Department. It will evaluate the operation of Manufacturing and Quality activities in relation to compliance to Quality Standards and Regulations and recommend where corrections or improvements are indicated. The position will provide direct support to Quality Management/Quality personnel regarding the operation of the department and Quality System. It will provide support to other departmental activities as directed. Job Responsibilities: Processes: Oversee the operation of the Quality System process related to product, process, and/or test method Validation and Re-Validation Oversee the Installation, Operational and Performance Qualification activities for equipment, product, or systems installed including those requiring computerized operation/interfacing Coordinate other activities associated with installation and proper configuration of new equipment as directed Provide assistance to the Manufacturers and R&D departments in the development and validation of new products and Manufacturing/Quality Control processes Review and approve internal operating procedures and specifications Support NCR and CAPA: Capture data associated with product deviations, product non-conformances, CAPAs, scrap and rework, and analyzing the data for the purpose of Quality Improvement and reporting Quality Improvement – Data Analysis: Provide leadership and direction and promote Quality Improvement Processes Coordinate, and analyze databases associated with oversight of the Quality System and its reporting process Quality initiatives: Provide quality engineering support for supplier changes and resolution of issues at suppliers Identify new quality improvement initiatives / projects in accordance with cGMP expectations to improve compliance, quality levels (reducing defects), and improve operational efficiencies Work with manufacturing and other functional groups on manufacturing regulatory compliance issue Support training program by delivering assigned training tasks Inspections: Support with federal, state, and local regulatory officials during regulatory inspections Support in internal and vendor quality system audits as applicable Assist with adherence to all Federal, State and Local Regulations controlling the manufacture of medical devices Skills & Experience Required: Bachelor's degree in relevant field 3-5 years Minimum in Medical Device or Pharmaceutical Industry or similar experience 3-5 years Minimum in a Quality Role 3-5 years Minimum in a Validation Engineering Role Minimum of 3 years working with electromechanical devices ASQ Certification as a Quality Engineer or equivalent highly desired Experience with statistical analysis of data Experience with statistical sampling requirements for Process Validation Familiar with ISO 13485 Quality System Standards, FDA Quality System Regulations, GMPs, and/or other international medical device regulations