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Automated Inspection Engineer - Quality Engineer II

Req ID: J2270758

  • Ubicación
    Clinton, MA, Massachusetts, United States of America
    Devens, MA, Massachusetts, United States of America
  • Categoría Ingenieria
  • Publicado lunes, 3 de mayo de 2021
  • Tipo Tiempo completo

Descripción del Trabajo

JOB SUMMARY
Work within the Metrology team in a Quality Engineering role that supports Automated Inspection, Calibration and Incoming Inspection. Ensure complete compliance to all applicable statutory and regulatory standards including cGMP/QSR, ISO13485 and 21CFR820, Part 11.


ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Promote and participate in activities to support local and global safety practices and programs.

  • Act as a change agent and participant in continuous improvement activities towards customer focus, process planning and improvement, and employee empowerment.

  • Analyzes inspection and testing processes, mechanisms and equipment.

  • Analyzes and interprets engineering drawings with applicable Geometric Dimensioning and Tolerancing (GD&T).

  • Participates in the Advanced Quality Planning (AQP) process.

  • Participates as a Site Subject Matter Expert (SME) for Statistical Process Control (SPC).

  • Participates as a Department Representative as a contributor / participant in internal, corporate, customer and third-party audits.

  • Participates as a Department Action Team Leader / Member for Corrective Actions (CA), Preventative Actions (PA) and A3 Projects.

  • Participates as the Site Subject Matter Expert (SME) for the deployment of new or modified automated inspection solutions, up to and including, selection, design, implementation and qualification of fixtures, gages, standards and methods.

  • Supports quoting activities by participation in initial process design, development, and implementation phases.

  • Support of Nypro Clinton Program Management objectives / initiatives.

  • Support of Nypro Clinton commercial objectives / initiatives

  • Other responsibilities to be assigned as appropriate.

  • Relocation assistance may be available.

JOB QUALIFICATIONS / KNOWLEDGE REQUIREMENTS

The following are requirements of the posted job requirements:

  • B.S. in a Technical or Applied Science discipline (or equivalent Quality / Process / Product / Process)

  • 2 – 4 years engineering experience and 0 – 3 years in a supervisory capacity.

  • Strong communication and problem-solving skills required.

  • Strong interpersonal and conflict management skills.

The following are preferred in job candidates:

  • Applied knowledge of Blueprint reading and Geometric Dimensioning and Tolerancing (GD&T) practices to industry standards (ANSI, ASME, ISO).

  • Applied experience of Statistical tools for evaluating process capability (Cpk) and process control (SPC).

  • Applied experience in Measurement System Analysis (MSA), such as Gage Repeatability & Reproducibility (GR&R) studies, Gage Attribute studies.

  • Applied resource management experience, particularly in a shared services application.

  • Technical writing skills, including work instruction / procedure, testing protocol and summary report creation.

  • Experience with complex inspection systems, such as Coordinate Measurement Machines (CMMs), Vision Systems, Height Gauges, Force Testers.

  • Proficient programming experience with inspection software such as PC-DMIS, MeasureMind3D, Create Job Requisition 03:02 PM 04/27/2021 Page 2 of 5 Zone3, MeasureX, Keyence VR, Visual Basic (VB) / Visual Basic for Applications (VBA), Python and BlueHill. Experience with SolidWorks, Creo, AutoCad or other Computer Aided Drafting (CAD) software packages.

  • Experience with Minitab, LotusNotes, SAP, Predisys SPC, and Adobe Writer applications.

  • Experience with simple inspection systems, such as Optical Comparators, Height Gauges, Drop Indicators, Calipers, Micrometers, Pin gauges.

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