Do you want to join one of the World's Most Admired Companies? Are you looking to be part of a dynamic and growing organization, who's company culture is centered on empowering its employees to make decisions? As one of the world's largest electronic manufacturing & supply chain logistics companies,Jabil is focused on hiring the best people! About Our Company Nypro Healthcare, a Jabil 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 Healthcares 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. NPI Quality Engineer III - FinPack Job Summary Represents the quality function in the deployment of new or modified systems, serving as a key contributor to new program / product introduction delivery activities. Represents the quality function in the operational sustaining activities, serving as a facilitator and driver of continuous improvement and problem resolution activities. Ensure complete compliance to all applicable statutory and regulatory standards including cGMP/QSR, ISO13485 and 21CFR820, Part 11. Essential Duties & Responsibilities Promote and participate in activities to support local and global safety practices and programs Promote and participate in continuous improvement activities towards customer focus and process planning and improvement Serve as a Department Subject Matter Expert (SME) for Verification, Commissioning, Qualification, Validation of new or modified systems, including equipment, test methods, environmental controls and software, etc Serve as a Department Contributor for Advanced Quality Planning (AQP) Serve as a Department Action Team Leader for Corrective Actions (CA), Preventative Actions (PA) and A3 Projects Responsible for development, maintenance and site compliance of the Master Validation Plan (MVP), Commissioning and Qualification Plan (C&Q), Project Validation Plan (PVP), etc as established through local site and customer requirements Plan, promote and participate in program / project change control new program / product introduction activities including the creation, maintenance and compliance of test protocols, test plans, test cases, summary reports, test / process deviations, etc Plan, promote and participate in program / project change control operational sustaining activities including the creation, maintenance and compliance of standard operating procedures, work instructions, purchasing specifications, incoming inspection records, inspection / quality plans, etc Plan, promote and participate in commercial support problem solving activities including resolution of area non-conforming product / process events, process change / deviation authorizations, product quarantine events and complaint investigations, etc As appropriate, may be required to directly interface with customers, suppliers, and other local site departmental resources at all levels of these organizations. Other responsibilities to be assigned as appropriate Education & Experience Requirements The following are requirements of the posted job requirements: B.S. in a Technical or Applied Science discipline or equivalent, with 5 7 years engineering experience. No experience in a supervisory capacity required Strong communication and problem-solving skills required Strong interpersonal and conflict management skills required Technical writing skills, including work instruction / procedure, testing protocol and summary report creation The following are preferred in job candidates: Applied experience in Master Validation Planning (MVP), Commissioning and Qualification (C&Q), etc for asset / system deployment Applied experience in Measurement System Analysis (MSA) and Gage Repeatability and Reproducibility (GR&R) Applied experience in high-speed automation asset deployment and retrofitting Applied experience working with medical devices, combination devices, and pharmaceutical delivery systems Applied experience in industry regulated under standards such as cGMP/QSR, ISO13485 and 21CFR820, Part 11 The following are not required but considered valued skills in job candidates: Experience with SolidWorks, Creo, AutoCad or other Computer Aided Drafting (CAD) software packages Experience with Minitab, LotusNotes, SAP, Predisys SPC, and Adobe Write applications Experience working in an ISO14644 Class 8 cleanroom work environment ASQ certifications such as Certified Quality Manager (CQM), Certified Quality Auditor (CQA), or Certified Quality Engineer (CQE) Lean certifications such as Six Sigma Green Belt (SSGB) or Six Sigma Black Belt (SSBB) Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identify, age, disability, genetic information, veteran status, or any other characteristic protected by law. Associated topics: business, cost efficient, industrial engineer, manufacturing engineer, methods engineer, project, sap, supply, supply chain
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