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Quality Systems Analyst

Req ID: J2273004

  • Ubicación
    Fremont, CA, California, United States of America
  • Categoría Grupo de Calidad
  • Publicado jueves, 27 de mayo de 2021
  • Tipo Tiempo completo

Descripción del Trabajo

JOB SUMMARY

The Quality Systems Analyst (QSA) is responsible for ensuring the Quality Management System meets or exceeds customer quality and applicable regulatory requirements for products and services. The role breaks into 2 main aspects. Document and Records Control management as well as QMS sustainability.  This includes being responsible for maintaining the site’s documents and records to ISO 9001:2015 and Jabil EMS Global Quality requirements while also supporting the FRE Senior Quality Systems Engineer to drive QMS maturity and sustainability.

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Quality Management Systems (QMS)
    • Performs trend analysis on key quality metrics including FPY, DPM, OTD, CRR
    • Identifies Quality System issues and recommend / implement corrective and preventative actions.
    • Audit and administer CAPA and Audit Management Processes – Pilgrim SmartSolve SME
    • Acts as internal auditor for the Quality Management System
    • Analysis of site QMS data to support bi-annual Mgt Review process.
    • Tracks document Waiver and Extension requests and identify areas for QMS document improvements to prevent waiver usage
    • Interfaces with the Sr Quality System Engineer and other site department leaders.
    • Aligns with Critical Manufacturing and JDoc to support migration accordingly, inclusive of maintaining latest revisions of Customer documents
    • Tracks progress of follow-up items from TUV, Global Quality, Customer & Internal audit findings
    • Coordinates Quality Systems continuous improvement projects with other functions as well as compliance with regulatory, customer and company quality requirements
  • Document Control responsibilities
    • Understands and maintains QMS procedures ensuring alignment with ISO9001, site, & business requirements
    • Implements and maintains the global and site Document Control requirements. Sets up and maintains all documents accordingly.  This includes storing, maintaining, logging, distributing, and ensuring availability of all documentation in hardcopy and electronic form for the site.
    • Follows the site Document Approval Matrix for document approvals prior to releasing in the Quality Systems Listing
    • Reviews all site documents for completeness and compliance prior to adding to the Quality Systems Listing
    • Ensures 100% of the site documents meet their 2-year review requirement
    • Responsible for document distribution per defined requirements:
      • Following the Red Stamp process
      • Ensuring that all distributed copies are traceable and logged
      • Verifying no uncontrolled documents are on the shop floor
      • Maintains the process for ensuring only the latest Customer documents are available
    • Responsible for the external document (e.g. Global, Customer, Standards, Regulatory) gap assessment process
    • As the site Records Custodian, establishes and maintains an effective site Records Control System:
      • Storage, identification, retrieval of electronic files as well as hardcopy files by destruction year
      • Working with the Sr. Quality Systems Engineer to develop Functional Records Custodians Team

JOB QUALIFICATIONS

KNOWLEDGE REQUIREMENTS

  • Able to clearly speak English. Spanish or Vietnamese a plus
  • Expert knowledge of Doc Control systems
  • Ability to comprehend and support implementation of document improvement systems (e.g. Critical Manufacturing)
  • Detail oriented with a sincere desire to produce accurate, quality oriented work and with a positive attitude
  • Must be an excellent communicator and work well with all levels of the organization
  • Proficiency in use of personal computers, Microsoft Office products (Excel, Word and PowerPoint), and metric reporting skills required
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