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Quality Systems Engineer

Req ID: J2288601

  • Ubicación
    Clinton, MA, Massachusetts, United States of America
  • Categoría Grupo de Calidad
  • Publicado jueves, 30 de septiembre de 2021
  • Tipo Tiempo completo
  • Tipo de Empleo Empleado Permanente

Descripción del Trabajo

Position Summary:

This position has the responsibility and authority to participating in the development, documentation, maintenance, and improvement of Customer Complaint Program. The incumbent will be responsible for ensuring continued compliance to associated regulations, standards, and corporate policies. Additional responsibilities include supporting internal and external auditing programs, Quality Management System elements as required.

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

Customer Complaints Program

  • Facilitate CC process for ensuring that corrective actions (CAPA) are completed in accordance with relevant ISO requirements (ISO 13485, ISO 14971 & FDA 21 CFR part 820), Jabil Advance Problem Solving methods, and that documentation is complete and compliant with requirements.
  • As a CC coordinator, quality engineer shall facilitate efficient and effective processing of CCs
  • Regularly communicate with Engineering, Quality, and manufacturing to implement robust CC within defined timeline.
  • Track and Trend CC metrics including but not limited to weekly and monthly CC metrics
  • Coordinate with cross-functional team for root cause analysis and corrective & preventive actions
  • Conduct Verification of Effectiveness for the CCs
  • Participate in CC Review Board meetings and get required support from senior management team for CC implementation
  • Complete harmonization and gap assessment reviews for documents associated to CC process
  • Facilitate meetings with customer to support closure of open CCs and respond to customer queries
  • Facilitate investigations on Return Material Authorization requests submitted by customer

Audit Support

  • Assists with internal audits, external audits, and FDA inspections
  • Participates in Second/Third party audits and provides input to Jabil response to any findings

Quality Engineering Support

  • As required, assists in development of quality plans, work instructions, procedures, harmonization, periodic document reviews, change controls, process change authorizations etc.
  • May perform other quality related duties and responsibilities as assigned

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

  • B.S. in a Technical or Applied Science discipline (or equivalent Quality / Process / Project / Automation / Injection Molding experience), with 0-3 years engineering experience. No experience in a supervisory category is required.
  • Must have strong verbal and written communication and interpersonal skills
  • Organizational and planning skills are required to plan, execute, and track quality commitments
  • Strong problem-solving skills
  • Understanding of project management (experience preferred)
  • Ability to multitask and perform efficiently and independently
  • Knowledge of various quality system methodologies such as 8D, Lean, 5 Why’s, Pareto Analysis, PFMEA, PPAP etc. preferred
  • Internship / experience in the regulated industry with standards such as cGMP/QSR, ISO 13485 and 21CFR 820 Part 11 preferred
  • The following are not required, but would be considered valuable skills/experience in potential candidates:
    • Experience working with medical devices, combination devices, and/or pharmaceutical delivery systems
    • Experience with Minitab, Lotus Notes, SAP, SPC and Microsoft Office Applications
    • ASQ certifications such as Certified Quality Engineer CQE or Certified Quality Auditor CQA
    • Lean certifications such as Six Sigma Green Belt SSGB or Six Sigma Black Belt SSBB

Organization Linkages:  List the titles of individuals and organizations with which this position has the most frequent and significant contact.  Briefly describe the nature of those contacts.

  • Department Staff Member
  • Site Quality Lead and Senior Site Management
  • Work Cell Manager and Site Department Managers
  • Customer

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