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Quality Engineer II - NPI Molding

About Our Company
Nypro Healthcare, a Jabil Inc. company, offers healthcare and pharmaceutical customers the widest array of design and manufacturing capabilities in the industry. With more than 40 years of experience, our highly specialized teams meet the complex and regulated demands of the diagnostics, medical devices and pharmaceutical markets enabling the world's leading brands to fulfill their market potential. Nypro Healthcare's customer focused services range from ideation to device development support, engineering, supply chain optimization, vertical plastics and electronics to device assembly operations, all at our purpose-built facilities that support stringent healthcare requirements and protect our customers' intellectual property.
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. Investigates problems and recommends disposition, modification 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 & Responsibilities
Maintains quality evaluation and control plans and protocols for processing materials into finished products.
Analyzes inspection and testing processes, mechanisms and equipment.
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 assist in process validations/qualifications in accordance with Nypro and customer requirements.
Assist with internal supplier third party and FDA quality audits as needed.
May assist in support of plant Quality System software validation as needed.
Support 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.
Education & Experience Requirements
BS or equivalent
2-4 years of experience
.
Jabil is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, creed, religion, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other status protected by law.



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