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Consultant, Quality Engineer, EU MDR, Medical Device

Company: GForce Life Sciences
Location: Indianapolis
Posted on: October 13, 2019

Job Description:

SummaryOur client, a growing medical device company, has engaged GForce Life Sciences, to identify a strong Quality Engineer to support the implementation of Medical Device Regulations (EU) 2017/745 requirements. This will entail resolving issues by identifying and applying solutions from acquired technical experience and guided precedents. Coordinate customer requirements and assist in the coordination of projects with other quality engineers. Work effectively & productively with all departments by developing a team atmosphere.
Duties / Expectations of Role
The Quality Engineer should be familiar with quality function, process flows, control plans, build instructions, process verification and validations (IQ/OQ/PQ), and quality inspection.

  • Coordinate customer requirements, spreadsheets, and documentation to reach their MDR compliance.
  • Coordinate activities between other contracted QEs
  • Validating document testing, process flow and document regulations
  • Plan and coordinate the project tasks and resolve/escalate upcoming issues.
  • Report the project progress to the site leads.
  • Chosen QE(s) will implement, communicate, execute, receive, review, track, report, and archive all documentation as objective evidence as requested for purpose of compliance to EU MDR, Corporate Procedures, 21 CFR Part 820.50 and 21 CFR Part 820.120.
  • Ensure customers and the organization are EU MDR compliant via objective evidence/documentation gathered over the course of the project.
    Mandatory Requirements
    • Bachelor of Science in Engineering or an alternative Bachelor's degree program with certification as a quality engineer (e.g. CQE).
    • 5+ years of experience in a Quality Engineering role within Medical Device
    • Experience working in a Supplier Quality or Continuity environment
    • Working understanding of QSR/ISO regulations, design assurance, FMEA, Process Flow, and product testing methods.
    • Experience in process validations: creating, reviewing, and approving protocols and reports, and execution of protocols.
    • Experience to include all components of production and process controls including, IQ, OQ, PQ, PPQ, manufacturing equipment software (CSV), and TMV/MSA.
    • Experience in pFMEA, manufacturing process flows, control plans, and quality records are required.
    • Expert knowledge of blueprint reading and geometric dimensioning and tolerancing
    • Knowledge of statistics, manufacturing process control and validation, and process capability
    • Medical device manufacturing experience
    • Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.).
    • Ability to deliver, meet deadlines and have results orientation.
    • Able to communicate both orally and in written form to multiple levels of the company.
    • Microsoft Office Suite Experience
      Nice to Have Requirements
      • Certification as a quality engineer (e.g. CQE) or the Reliability Engineer Certification (CRE) granted through the American Society of Quality (ASQ) preferred.
      • Knowledge of medical manufacturing, specifically related to ISO 13485, is desired.
      • Understanding of Medical Device Regulations (EU) 2017/745,
      • Working knowledge of ISO 13485
      • Working knowledge of 21-CFR-820
      • Working knowledge of FDA Design Controls/ISO13485 and medical device product development
        Term & Start
        • 7 months+
        • Start ASAP
        • IN or Remote Work is a possibility

Keywords: GForce Life Sciences, Indianapolis , Consultant, Quality Engineer, EU MDR, Medical Device, Professions , Indianapolis, Indiana

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