Essential Duties & Responsibilities • Ensure plant conformance with validate processes and customer requirements and expectations. • Train and assess the competency of personnel to effectively perform all required inspections to identify non confirming product. • Train and assess competency of the proper review and approval of Device History Records by quality personnel. • Audit inspections to ensure they continue to be performed in accordance with internal or customer driven requirements. • Audit manufacturing processed to identify areas of improvement. • Communicate, identify, and facilitate investigations into customer complaints issues. • Facilitate communication between operations, engineering, quality and customer (where appropriate) to optimize continuous improvement and issue resolution results. • Segregation, control and disposition of non-conforming product. • Identify, recommend and perform quality training as needed. • Ensure maintenance and control of production quality records. • Audit root cause and corrective actions resulting from process control variances. • Supports the appropriate team personnel in the investigation of root causes and corrective action of internal rejects, corrective/preventive action, out of control SPC points, and customer complaints. • Identify needs for SPC and statistical studies and perform as necessary. • Continually study the existing quality system and make recommendations for improvements. • Perform improvements projects as identified. • Facilitate site 3rd party audits and internal audits. • Support in evaluation of customer specification and procedures. • Manage all activities related to the MCI’s and QS’s. Knowledge | Experience | Skills • Knowledge in Microsoft Office tools • Technical writing • Understanding of injection molding process preferred • 3+ Years supervisory experience • Leadership skills • Multi-task in fast-paced environment, manage multiple tasks and changing priorities using strong organization and prioritization skills • Quickly understand concepts and think through possible solutions and implications • Read and interpret quality and specification data with an understanding of company policies, procedures, and internal controls • Effectively present information and respond to questions from groups of managers and colleagues • Read, analyze and interpret documents such as drawings, blueprints, and production schedules • Strong analytical and troubleshooting/problem solving skills with an emphasis on attention to detail balanced with a big picture focus and ability to work cooperatively with others. Collects and researches data, designs work flows, and procedures • Computer Skills; spreadsheet, word processing, and electronic mail systems. • Bilingual: English/Spanish preferred #INDHP