Develops and implements quality plans, programs, and procedures using quality control statistics, lean manufacturing concepts, and analyses. Ensures that performance and product quality conforms to established company, customer and requirements. Reviews, analyzes and reports on quality discrepancies related to assembly and process. Investigates problems and develops dispositions, modifications and corrective actions for recurring or non-recurring discrepancies. Interfaces with manufacturing, engineering, customer, vendor and subcontractor representatives to ensure requirements are met.
ESSENTIAL DUTIES AND RESPONSIBILITIES
· Develops, modifies, applies and maintains quality evaluation and control plans and protocols for processing materials into partially finished or finished products.
· Develops and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
· Analyzes inspection and testing processes, mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for, products or materials that do not meet required standards and specifications.
· Assists with managing Part Files that define statistical analysis requirements and any associated control limits, as needed, for Predisys SPC/SPC.
· Audits quality systems for deficiency identification and correction.
· Ensures that corrective measures meet acceptable reliability standards and that documentation is complete and compliant with requirements.
· May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
· Writes, reviews, approves process validations/qualifications in accordance with Nypro and customer requirements.
· Assists in the process for ensuring that corrective actions (CAPA) are completed in accordance with relevant ISO requirements (ISO 9001 and ISO 13485), Nypro Advance Problem Solving methods, and that documentation is complete and compliant with requirements.
· May manage the internal supplier third party and FDA quality audits.
· Support plant Quality System software validation as needed.
· Support all company safety and quality programs and initiatives.
· May perform other duties and responsibilities as assigned.
· Proficiency in use of personal computers, Microsoft Office products (Excel, Word and PowerPoint) and e-mail skills required.