• Engineer -inter

    Job Location(s) US-NJ-Mahwah
    Posted Date 1 month ago(4/27/2018 5:08 PM)
    Job ID
    2018-29247
    Category
    Engineering
    Position Type
    Contract (Full-Time)
    # of Openings
    1
  • Overview

    Project/Quality Engineer 

    • Facilitate change control activities regarding the direct part marking efforts for in-house and vended products, including the maintenance of large Excel change control trackers, creating relationships and following up with all change management stakeholders to meet project timelines.
    • Lead change control activites as related to company’s Unique Device Indentification efforts in regards to changes in inspection documents and detailed operation sheets.

    Qualifications

    • Bachelor’s of Science Degree in Engineering (Mechanical, Industrial, Biomedical, Biomechanical prefered) 
    • 3+ years experience as an Operations Engineer in a regulated production/manufacturing environment. Prefer experience within a medical device or pharmaceutical industry.
    • Demonstrated applied knowledge of FDA and international medical device regulations and validation activities a plus.
    • Demonstrated ability to effectively work cross functionally with other departments including Quality, Purchasing, and Product Development.
    • Demonstrated computer skills using Microsoft Office applications, especially Excel, including Word, PowerPoint, etc.)
    • Knowledge of QMS systems, ERP system would be highly desired (Windchill and Oracle preferred).
    • Demonstrated problem-solving and troubleshooting skills.
    • Demonstrated interpersonal and communication skills.
    • Demonstrated ability to exhibit a positive, energetic approach to teamwork, with a high degree of emphasis on accountability.
    • Demonstrated ability to advocate product excellence and quality.
    • Demonstrated ability to respond to the urgent needs of the team, with proven track record of meeting deadlines.
    • Ensure high level of compliance to FDA QSR/cGMPs and ISO standards in all assigned areas.
    • Participate in daily continuous process improvement activities as related to the direct part marking process.
    • Participate on project teams with internal departments to support product and/or process design and development ctivities.
    • Update inspection plans and operation sheets as related to product drawing changes.
    • Assist in development and execution of process and equipment validation/qualifications (IQ, OQ, PQ).
    • Submit product and/or process change control documentation and specifications.
    • Demonstrate results orientation, ability to multi-task, learn quickly, prioritize and accomplish work with limited supervision.
    • Direct responsibility to escalate issues to management that can impact project performance.

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed

    Need help finding the right job?

    We can recommend jobs specifically for you! Click here to get started.