Sr Quality Engineer

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Sr Quality Engineer

  • Specialty:

    Engineering
  • Title:

    Sr Quality Engineer
    • City:

      Mansfield
    • State:

      MA
    • Zip Code:

      02048
  • Start date:

    03-18-2020
  • Status:

    Closed
  • Assignment Type:

    Contract
  • Job Id:

    52730

Description

This position has the responsibility of working in the R&D and Quality Engineering MDR Workstream to plan and execute R&D/Quality activities to support the remediation of products relative to the European Medical Device Regulations (MDR), ensuring products maintain quality standards, comply with regulatory and compliance standards. Job responsibilities include providing technical leadership, strategic and tactical planning, and providing subject matter expertise to more junior engineering staff.


This workstream is responsible for ensuring all product related documentation submitted as part of a technical file is remediated to standards required by the MDR legislation. In addition new processes must be established for NPD projects to ensure future MDR compliance – including those within the current project pipeline and future project initiation.

Essential Functions

 

  • Update of all R&D/Quality documentation (e.g. Design History Files, Design Control documents, Verification/Validation documentation, Risk Management files) in line with the General Safety and performance requirements specified within the MDR legislation in line with new product groupings.
  • Prepares design drawings and acts as a consultant in the preparation of final or modified drawings in line with MDR requirements.
  • Ensure that all product testing data (e.g. MRI, biocompatibility) is remediated or developed to MDR standards.
  • Update existing R&D/Quality processes for maintenance/creation of design history files and other supporting documentation.
  • Establish new processes for future NPD project initiation taking into account the increased evidence, scrutiny and costs of gaining product registration under the MDR legislation.
  • Prepare Design History files and other required supporting documentation for a notified body pilot.
  • Provides R&D engineering support for Quality and MDR compliance activities including correcting quality problems in released product, compliance with the new regulations and standards, support for Regulatory re-submissions, and remediation of quality records.


REQUIRED

  • Bachelor’s degree in Mechanical Engineering, Biomechanical Engineering, Engineering Mechanics or other related engineering field.
  • Experience 7-10 years minimum progressive experience in leading project teams in medical device design control
  • Competencies Ability to work effectively in a cross-functional team environment
  • High learning agility
  • Strong written and verbal communication and technical writing skills
  • Analytical approach to problem solving

#DMS-A

#MON

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