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Quality & Regulatory Specialist

Company: Zoll - Respicardia
Location: Minnetonka
Posted on: January 5, 2022

Job Description:

Please note; as per the Federal mandate, ZOLL now requires COVID vaccinations subject to legal exemptions.
The Quality & Regulatory Specialist at ZOLL - Respicardia is responsible for coordinating all necessary quality and regulatory activities related to the Quality Management System (QMS) and associated documentation. This role is part of a multidisciplinary team supporting ZOLL Respicardias commercial and continuous improvement activities.
This position reports to the Manager of Quality and Regulatory Affairs at our Minnetonka, Minnesota facility.
What youll do:

  • Drive and sustain improvement to the QMS to ensure ongoing regulatory and ISO 13485 compliance and that quality requirements for products, process, and/or the system will be fulfilled.
  • Create and support documentation updates to reflect current practices, emerging needs/changes, and improvements.
  • Coordinate, manage, and oversee various aspects of quality assurance activities such as quality review and approval of documents, training, nonconformance, lot traceability and segregation, supplier corrective action reports (SCAR), GMP compliance, GDP compliance, corrective and preventative action (CAPA), and complaint investigations to support operations activities.
  • Coordinate, manage, and oversee documentation generation and updates in the electronic Quality Management System. Support the organization with generating documents through the system and act as system administrator for final document release and administrative updates.
  • Coordinate user profile and training profile set up and changes for new and existing roles within the organization in the electronic Quality Management System. Work with other departments to rollout new training upload training/certification evidence and training due date changes.
  • Assist in key performance indicator (KPI) metric generation and reporting for key processes within the Quality Management System critical to the business requirements. Identify improvement opportunities and assist with projects to drive improvement.
  • Conduct internal/supplier audits and support external audit preparation and execution. Assist in the organization of responses and follow-on corrective actions.
  • Other duties as assigned.
    What were looking for:
    • Minimum 4-year degree in life science or related field. 5 years experience in advancing and maintaining medical device Quality Management Systems.
    • Medical device company experience.
    • Strong project management capabilities.
    • Excellent written and verbal communication.
    • Must be have strong interpersonal skills.
    • Ability to produce accurate work in a timely manner.
    • Strength in problem solving is essential.
    • Strong computer skills experience with document control software is a plus.
    • Experience with active implantable medical devices a plus.
    • Internal and supplier audit experience of Quality Management Systems a plus.
    • RAC certification a plus.
      You take care of Zoll - Respicardia and we'll take care of you!
      ZOLL provides:
      • A casual work environment.
      • Competitive salaries.
      • A compensation structure that rewards contribution and hard work.
        Benefits include:
        • 401(k)
        • Medical
        • Dental
        • Vision
        • Life
        • AD&D
        • FSA
        • STD/LTD
        • Paid Time Off
        • Tuition assistance
          You are qualified, interested and want to apply!
          Please visit us at:
          ZOLL appreciates and values diversity. We are an equal opportunity employer and do not discriminate in hiring or employment on the basis of race, color, religion, national origin, citizenship, gender, gender identity, genetic information, marital status, sexual orientation, age, disability, veteran status, or any other characteristic protected by federal, state, or local law.
          ADA: ZOLL will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.
          https://www.respicardia.com/about/careers/remede.zoll.comby Jobble

Keywords: Zoll - Respicardia, Minnetonka , Quality & Regulatory Specialist, Other , Minnetonka, Minnesota

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