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Plastics Quality Engineer JobPosted by: Nypro
Posted date: 2012-Jun-09
Location: Clinton, MA
Develops and implements quality plans, programs, and procedures using quality control statistics, lean manufacturing concepts, and analyses. Ensures that performance and product quality conform to established company and customer requirements. Reviews, analyzes, and reports on quality discrepancies related to the assembly and molding 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 position's key responsibilities as they apply to new product introduction.
Education and/or Experience:
BS Degree or equivalent in an Engineering discipline. Requires 6 - 8 yrs experience as a Quality Engineer with injection molds and automation (preferably with medical devices).
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 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
Audits quality systems for deficiency identification and correction
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 and approves process validations/qualifications in accordance with Nypro and customer requirements
Assists in the process of 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
Assists in the preparation of Drug Master Files (DMF) submissions and reports. DMFs are to be sumeitted by Nypro's Official Correspondent to the FDA
Supports plant Quality System software validation as needed as well as all company safety and quality programs and initiatives
Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/ position
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