Demant

Quality Management System Engineer

Department Demant Group Services Operations
Job Locations US-NJ-Somerset
Job ID
2021-11101

Overview

QUALITY MANAGEMENT SYSTEM ENGINEER - SOMERSET, NJ

 

Duties include execution of all quality-related activities.  This includes but is not limited to Quality System; Quality Engineering functions; Inspection activities, Gage Calibration and Document Control.  Responsible for all Documentation Control activities associated with Quality System requirements, including Device History Records (DHR), employee training records, validations, and other Quality Records.  Responsible for ongoing adherence to external regulations as required by the Food and Drug Administration GMP, ISO 13485 and other applicable regulations. Reviews and approves changes to local or external Instructions

Responsibilities

  • Administration and Maintenance of the Quality Management System
  • Updating of the Quality Management System.
  • Cooperation with administrators of Quality Management System at Demant Holding.
  • Collaboration with other departments in creating, implementing and updating procedures.
  • Supervision over work of a group of internal auditors.
  • Supervision over system of corrective, preventive and improving actions (CAPA system).
  • Performing evolve as CAPA responsible and QA representative (role related to the assessment and approval/ closing of notification and other stages in CAPA system) in CAPA tool.
  • Conducting adaptation training in Quality Management System.
  • Performing evolve as Local Internal Quality Audit Coordinator - approving reports from internal audits, appointing  internal auditors, preparing an internal audit plan for US, managing list of internal auditors, ensuring appropriate competences among the group of internal auditors.
  • Scheduled performance of internal audits in accordance with the current audit plan and the applicable procedure.
  • Coordination and participation in external audits.
  • Supervision over planned implementation of internal audit plan.
  • Knowledge and follow-up of QMS procedures.
  • Conducting internal training.
  • Coordinating work on updating Quality Management System between departments.
  • Coordination of activities related to maintenance and improvement of Quality Management System.
  • Supervision of documentation
  • Review, approval and process of QMS documents.
  • Administration of Mexico documentation web directories.
  • Maintain hard copy files of local documentation.
  • Create QMS and QA instructions and documents.
  • Conduct training of relevant Quality QMS documents.
  • Creating quality reports.
  • Creating a report for top management.
  • Preparing data for the management review of the Quality Management System.
  • System administration:
  • Local Document Control.
  • CAPA
  • NCR
  • Additional function - Internal Auditor of Quality Management System (QMS).

Qualifications

  • Engineering degree
  • 3 Years minimum experience as a Quality Management System Engineer in a Medical Device Manufacturing company
  • Knowledge in the following fields:
    • ISO13485
    • FDA 21 CFR 820
    • Internal Audits
    • External Audits
    • Document Control Management

The Company is an Equal Opportunity / Affirmative Action employer, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status.

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