• Quality Engineer - sr

    Job Location(s) US-NJ-Allendale
    Posted Date 1 month ago(3/22/2018 12:45 PM)
    Job ID
    2018-29043
    Category
    Quality Assurance
    Position Type
    Contract (Full-Time)
    # of Openings
    1
  • Overview

    The hiring manager still wants to consider candidates:

    The tasks are:

    1. To support risk file update (experience with DFMEA, Risk Management and Design desired)

    2. To support biocompatibility safety assessment data collection and assessment.

    3. Will require communicating with global suppliers and manufacturing partners.

    4. To support Product Environmental Compliance assessments. Experience with Medical Device Regulations, ISO 13485, RoHS, biocompatibility, risk management desired. We’re looking for someone who has 2-3 years’ experience in Med Dev, degree in engineering

    Responsibilities

    • To support risk file update (experience with DFMEA, Risk Management and Design desired) 
    • To support biocompatibility safety assessment data collection and assessment. 
    • Will require communicating with global suppliers and manufacturing partners. 
    • To support Product Environmental Compliance assessments.

    Qualifications

    • Experience with Medical Device Regulations, ISO 13485, RoHS, biocompatibility, risk management desired. 
    • We’re looking for someone who has 2-3 years’ experience in Med Device Industry.
    • Knowledge of EU MDR, ISO 13485 is highly preferred.
    • Degree in Engineering, preferably Biomedical/Mechanical/Materials.

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