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Quality Systems Specialist (Medical Device)

Req ID: J2277431

  • Ubicación
    Clinton, MA, Massachusetts, United States of America
  • Categoría Grupo de Calidad
  • Publicado lunes, 19 de julio de 2021
  • Tipo Tiempo completo

Descripción del Trabajo

The position of Quality Systems Engineer / Quality Engineer / QMS Administrator is responsible for supporting the product development process and quality management system at Jabil Healthcare Engineering & Technology (JHET) Clinton. Individual is expected to have strong background in ISO 9001, ISO 13485, ISO 14971 and/or 21CFR830.20 to facilitate organization and project team compliance with the JHET Clinton Quality Management System (QMS). Role will report to Quality Discipline Lead.

PRIMARY DUTIES AND RESPONSIBILITIES

- Manage QMS processes and documentation including, but not limited to training records, calibration records, approved supplier list (ASL), supplier records, CAD/drawings product data management (PDM), engineering change orders (ECO), non-conforming material review (NCMR), corrective and preventative actions (CAPA) and document control

- Develop and/or update QMS procedures and templates

- Identify, qualify and manage suppliers

- Lead internal audits and document reviews

- Support notified body / ISO registrar and client audits

- Establish, encourage use of and participate in continuous improvement of processes, procedures and standard tools related to design controls, risk management, supplier management and prototype assembly at Jabil

- Develop, participate in and/or review project design control (product requirements, design inputs, design & development plans, design reviews etc.) and risk management (plan, HARA, FMEA, report, etc.) documentation with project teams.

- Collect and manage content of project design history files (DHF)

- Provide guidance to project teams and clients on compliance with the QMS

- Contribute to project planning through proposal development and review


MINIMUM EDUCATIONAL REQUIREMENTS
Bachelors degree in engineering, science or technology related field
 

MINIMUM PRIOR WORK EXPERIENCE TYPICALLY REQUIRED

- Three to five years of experience working in product development environment with quality management system and/or design control requirements

- A history of developing products with multi-disciplinary teams

- Experience with medical industry regulation, risk management and design controls (ISO 9001, ISO 13485, ISO 14971, FDA, CFR, etc.)

ESSENTIAL SKILLS REQUIRED:

- Motivated, takes initiative

- Professional in manner and appearance

- Good interpersonal skills

- Excellent written and verbal communication skills

- Strong mechanical aptitude

- Learns and understands information quickly

- Attention to detail

- Commitment to excellence and high ethical standards

- Strong organizational, problem-solving, and analytical skills

- Ability to manage priorities and support multiple projects effectively

- Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm

- Passionate about working in a team with other disciplines (Business Development, Research, Human Factors, Design, Engineering, Implementation)

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