JOB SUMMARY
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 regulatory requirements. Reviews, analyzes and reports on quality discrepancies related to assembly and process. Leads investigation of 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. Has primary responsibility for planning and implementing the positions key responsibilities as they apply to new product introduction.
ESSENTIAL DUTIES AND RESPONSIBILITIES
· Leads the development, modification, and maintenance of quality evaluation and control plans and protocols for processing materials into partially finished or finished products.
· Leads the development and implementation of methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
· Leads the design and analysis of inspection and testing processes, mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine 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.
· 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 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.
· May provide direction and mentoring to less experienced QA Engineers.
· Demonstrated competence in Quality Engineering body of knowledge.
· Writes, reviews, approves process validations/qualifications in accordance with Nypro and customer requirements.
· Assist in the preparation of Drug Master Files (DMF) submissions (Healthcare GBU only) and Reports. DMFs are to be submitted by Nypro’s Official Correspondent to the FDA.
· Support plant Quality System software validation as needed.
· May manage the internal supplier third party and FDA quality audits.
· Support all company safety and quality programs and initiatives.
· May perform other duties and responsibilities as assigned.
JOB QUALIFICATIONS
KNOWLEDGE REQUIREMENTS
· Proficiency in use of personal computers, Microsoft Office products (Excel, Word and PowerPoint) and e-mail skills required.
bachelor degree with more that 8 years' experience of quality filed.
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