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NPI Quality Engineer II

Req ID: J2283498

  • Ubicación
    Clinton, MA, Massachusetts, United States of America
  • Categoría Grupo de Calidad
  • Publicado martes, 17 de agosto de 2021
  • Tipo Tiempo completo
  • Tipo de Empleo Empleado Permanente

Descripción del Trabajo

See Job Description below
      

  • 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
  • Ensures complete compliance to all applicable statutory and regulatory standards including cGMP/QSR, ISO 13485 and 21 CFR 820, Part 11

Key Responsibilities and End Results: (Essential responsibilities include but are not limited to the following):

  • Participates in activities to support local and global safety practices and programs
  • Participates in continuous improvement activities towards customer focus and process planning and improvement
  • Contributes 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.
  • Contributes as a Department Contributor for Advanced Quality Planning (AQP)
  • Contributes 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
  • Participates 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.
  • Participates 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.
  • Participates 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

Job Specifications The minimum education and experience required to perform this job competently.   

The following are requirements of the posted job requirements:

  • B.S. in a Technical or Applied Science discipline (or equivalent Quality / Process / Project / Automation Engineering experience), with 3 – 5 years engineering experience. No experience in a supervisory capacity required
  • Strong communication and problem-solving skills required
  • Strong interpersonal and conflict management skills required
  • Strong technical writing skills, including work instruction / procedure, testing protocol and summary report creation required

The following are preferred in job candidates:

  • Experience in Master Validation Planning (MVP), Commissioning and Qualification (C&Q), etc. for asset / system deployment
  • Experience in Measurement System Analysis (MSA) and Gage Repeatability and Reproducibility (GR&R)
  • Experience in high-speed automation asset deployment and retrofitting
  • Experience in industry regulated under standards such as cGMP/QSR, ISO 13485 and

21 CFR 820, Part 11

The following are not required but considered valued skills in job candidates:

  • Experience in high-speed automation asset deployment and retrofitting
  • Experience working with medical devices, combination devices, and pharmaceutical delivery systems
  • Experience with SolidWorks, Creo, AutoCad or other Computer Aided Drafting (CAD) software packages
  • Experience with Minitab, Lotus Notes, SAP, Predisys SPC, and Adobe Write applications
  • Experience working in an ISO 14644 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)

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