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    DHR Reviewer/Inspector, 2nd Shift - Wilmington, United States - restor3d

    restor3d
    restor3d Wilmington, United States

    3 weeks ago

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    Description

    Job Description

    Job DescriptionJob Summary:
    The DHR Reviewer/ Inspector will be responsible for product quality assurance activities. This includes interpretation and implementation of quality standards to routine manufacturing and product release activities.

    2nd Shift – Mon – Fri, 3:00pm – 11:30pm

    Essential Duties and Responsibilities:
    • Develop and maintain strong internal working relationships across restor3d.
    • Understand the objectives, responsibilities, and mission of the Sterility & Lot Release department and work towards those goals.
    • Prioritize and plan work activities; adapt for changing conditions.
    • Review labels for accuracy and precision.
    • Review of Device History Records to perform release of sub-assemblies and finished goods.
    • Inspect finished parts, and materials for conformance to quality control standards.
    • Initiate and participate in resolution of non-conforming materials.
    • Responsible for final product release sign-off.
    • Other responsibilities as assigned.

    Qualifications:
    • High School Diploma, GED, or equivalent work experience.
    • 18 months or more of Quality Assurance and experience in an FDA regulated environment is preferred – with QSR (21 CFR Part 820) experience if possible.
    • Proficient in Word and Excel.
    • Understanding of cGMP, GDP, ISO 13485.
    • Oracle experience a plus.

    Skills, Abilities, Competencies Required:
    • Excellent written and verbal communication skills.
    • Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail.
    • Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness.
    • Strong organizational, analytical, and time-management skills.
    • Able to self-motivate and work both independently and as part of a team.
    • Must be able to work in a team environment, execute responsibilities with minimal direct supervision, and have a high attention to detail.
    • Knowledge of FDA and ISO standards for Medical Devices is a plus.
    • Ability to multi-task, perform efficiently, and independently.
    restor3d is an Equal Opportunity Employer​​​​
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