Position Overview

Quality Systems Specialist will be an active contributor to maintain and improve quality systems associated to Quality Assurance activities, to ensure compliance and facilitate the MicroVention continuous improvement process efforts aimed to drive the support of the company quality policy and objectives.

This position will be part of the Quality Excellence department and will collaborate closely with Quality Assurance Engineering, Manufacturing Engineering, Operations, Regulatory Affairs, Complaints, Risk Management, and other areas, as required. Job duties:
  • Support internal activities related to Risk management / Complaints / Quality Assurance processes / Operations, etc. as required.
  • Support Manufacturing Related Complaints communications, tracking and analysis processes, incorporating operations and other strategic departments to promote actions to reduce recurrence, as required.
  • Support Risk Management local & corporative efforts to promote actions that support the company quality policy and objectives, as required.
  • Support activities to communicate and train other associates on quality system requirements related to Quality Assurance and Operations specific activities, in collaboration with Quality Systems, as required.
  • Support activities associated to third party audits including FDA, Notified Body, Corporate and international regulatory authorities’ audits, as well as Internal Audits, as required by the organization, in collaboration with Quality Systems, as required.
    1. Minimum a bachelor’s degree in a related to regulatory affairs and compliance.
    2. Minimum 3-5 years related medical device manufacturing experience.
    3. Good communications skills.
    4. Problem Solving Thinking.
    5. "Can do” approach.
    Desired Qualifications
    1. General knowledge of Medical devices product manufacturing.
    2. General knowledge of Medical devices regulations.
    3. Ability to understand the technology related to MicroVention product.
    4. General Knowledge on Medical devices’ Quality Systems & Quality Assurance approaches.
    5. Computer Skills including Office package.