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    Quality Engineer - Plymouth, United States - Interrad Medical

    Interrad Medical
    Interrad Medical Plymouth, United States

    1 week ago

    Default job background
    Upper Management / Consulting
    Description

    Background

    Interrad Medical, Inc. is a medical device company located in Plymouth, Minnesota. The company designs, develops and manufactures minimally invasive vascular access implantable medical devices for the US and OUS commercial markets.

    The Quality Engineer at Interrad Medical fulfills a multi-functional role. The Quality Engineer reports to the Director of Quality and provides Quality Assurance support to Manufacturing, Operations and Engineering.

    Primary Job Functions:

    • Ensure that medical devices manufactured by Interrad Medical are produced in accordance with the requirements of 21 CFR Part 820, ISO 13485, the Medical Device Directive and other applicable regulations and standards.
    • Coordinate the inspection of all materials that are purchased by Interrad Medical.
    • Coordinate and implement, where required, any non-conforming material reports, or deviations and supports customer complaint investigations.
    • Support and assist in the management of the documentation control system.
    • Maintain calibration and preventative maintenance records, coordinate calibration vendors, and ensure calibrations are consistent and compliant with requirements.
    • Provide feedback and work with outside vendors and contractors providing products or services to company with regards to quality issues. Work closely to ensure vendor issues are appropriately investigated, resolved, and documented.
    • Identify issues and recommend solutions for improving product quality and quality systems.
    • Review, analyze, and summarize results from incoming inspection with regards to yields, scrap, trending and lot release testing.
    • Coordinate and conduct vendor audits.
    • Supports internal audits.
    • Reviews and approves manufacturing records.
    • Other duties and tasks as assigned.

    Skills, Experience, and Education

    • BS degree, Engineering or Life Sciences preferred
    • 2 – 3 Years medical device or pharmaceutical manufacturing Quality Assurance experience
    • Engineering experience and demonstrated use of Quality tools/methodologies
    • Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner
    • Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
    • ASQ CQE or other certifications
    • Experience with QMS software (Grand Avenue preferred)
    • Familiar with measurement systems (SmartScope and Measure-X preferred)
    • Data analysis and statistical software (Minitab preferred)

    Demonstrated Skills:

    • Strong analytical, problem solving and communications skills.
    • Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.
    • Knowledge and experience of the interaction between product design and performance, relating design concepts and predicting design output outcomes
    • Self-motivator with a strong desire for hands-on development
    • Ability to work in a team environment
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