• Regulatory Affairs/ Quality Assurance Specialist

    Job Location(s) US-CA-San Jose
    Posted Date 3 weeks ago(9/29/2018 7:30 PM)
    Job ID
    2018-29871
    Category
    Quality Assurance
    Position Type
    Contract (Full-Time)
    # of Openings
    2
  • Overview

    RAQA Specialist - Int. 
    • BS in related field required, MS preferred. 

    Responsibilities

    • Provides general project support to departmental project managers. 
    • May help with the following: CAPAs, ECOs, data mining, quality systems procedures and work instructions, equipment and product validation, and special projects. 
    • Conducts revisions to Quality System procedures and documents. 
    • Submit and tracks Change Orders. 
    • Works with subject matter experts to interpret requirements and incorporate them into processes. 
    • Review product information, collaborate with subject matter experts to ensure accuracy of the information and investigate possible gaps, when necessary. 

    Qualifications

    • Bachelor’s or Master’s degree in engineering or life sciences (mechanical, electrical, industrial, software, biomedical, computer, biology, physics, chemistry, etc.) preferred. 
    • 3+ years of experience in medical device with Bachelor's degree; 1 year of experience with Master's degree. 
    • Regulatory Affairs Certification preferred. 
    • Working knowledge of data collection, data analysis, evaluation, and scientific method. 
    • Excellent organizational, problem-solving, and analytical skills to lead to sound, timely decisions 
    • Ability and versatility to manage changing priorities and workflow for multiple projects and deadlines 
    • Ability to interface with both technical and non-technical personnel at all organizational levels. 
    • Proficient with Microsoft Office and ability to learn corporate systems. 
    • Ability to understand and explain detailed regulatory compliance programs and/or issues. 
    • Ability to comply with constantly changing regulatory procedures and prioritize work effectively. 
    • Knowledge of applicable international regulations and standards (CFR, MDD, QSR, ISO 13485, CMDCAS, etc.).

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