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Senior Quality Management System Coordinator

Company: Orchid Orthopedics
Location: Anaheim
Posted on: May 14, 2022

Job Description:

SUMMARY OF POSITION
The Senior Quality Coordinator, QMS maintains the Quality Management System (QMS), ensures training is performed and recorded as required, and serves as a resource to the Quality and Regulatory functional groups.

SHIFT
ARC - Shift 1 ($0) (United States of America - California)

WHAT YOU WILL DO

  • Acts as site administrator for the Quality Management System (QMS)
  • Ensures documents in the QMS are up to date and reviewed at regular intervals
  • Collaborates with Orchid sites to establish QMS best practices and continuous improvement
  • Processes and reviews document creation/change requests
  • Assists document owners with writing, editing and training of new and revised procedures
  • Assists with coordinating, tracking, and recording training
  • Tracks and trends quality metrics
  • Participates in internal and/or external Inspections, as required
  • Verifies employee training is current and complete
  • Provides QMS training to employees
  • Assists with Document Control activities (including, but not limited to: closing jobs in Enterprise Resource Planning (ERP) system, scanning documentation, Device History Record (DHR) reviews)
  • Leads CAPAs and audit finding corrections related to the QMS
  • Complies with all Quality Management System (QMS) documentation requirements to meet/exceed Key Performance Indicators (KPIs) that support business objectives
  • Performs other duties as assigned

    WHAT WE ARE LOOKING FOR

    WORK EXPERIENCE
    3+ Years of Experience in A Manufacturing Environment (Required), 3+ years of experience in a quality role in a manufacturing environment (Required), Experience creating or modifying controlled documents (Required), Experience facilitating and delivering instructor-led, e-learning, and read-and-understand training (Preferred), Experience in document review (Preferred), Experience maintaining a high volume of data (Preferred), Experience with FDA and ISO systems relating to medical devices (Preferred), Experience with Structured Query Language (SQL) and SQL Server Reporting Services (SSRS) (Preferred)

    EDUCATION
    High School Or Equivalent Required, , ,

    CERTIFICATIONS
    None - N/A

    KNOWLEDGE & SKILLS THAT ENABLE SUCCESS
    Accuracy and Attention to Detail (Extensive Experience), Collaboration (Working Experience), Communication (Working Experience), Computer Knowledge (Working Experience), Data Entry (Working Experience), ISO 13485 (Working Experience), Organization (Working Experience), Problem Solving (Basic Knowledge), Training (Basic Knowledge), Web-Based Tools Management (Basic Knowledge)

    WHAT WE OFFER
    • Opportunity to work in a growing company
    • Ability to help people live a longer, more active life
    • Comprehensive benefit package
    • Ability to work in an organization that values:
      • Integrity First: We do the right thing
      • Teamwork: We are one Orchid
      • Results: Our results matter

        PHYSICAL REQUIREMENTS

        • Frequent and repetitive use of hands and fingers
        • Requires sitting for extended periods of time.
        • Wear safety glasses in production areas
        • Required: walk, stand, bend, stretch, squat, stoop, reach, speak, and hear
        • Able to work in a fast-paced, stressful, quality oriented environment

          ADDITIONAL REQUIREMENTS
          • Candidates offered employment may be required to submit to a pre-employment background check and pre-employment drug-screening based on position requirements
          • Candidates must be able to provide proof of eligibility to work in the United States through eVerify

            EOE, including disability/vetsby Jobble

Keywords: Orchid Orthopedics, Anaheim , Senior Quality Management System Coordinator, Executive , Anaheim, California

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