Nov 01, 2022

Medical Device QMS Specialist

$60,000 - $90,000 yearly
  • ZiphyCare, Inc
  • Hybrid (New York, NY, USA)
Full time Quality Regulatory

Job Description

Welcome to ZiphyCare! We're grateful you're interested in learning more about us to consider joining our team. At ZiphyCare, we are challenging the status quo in healthcare delivery. We believe that cost-effective quality healthcare can be delivered directly to every home.

We are looking for a Medical Device QMS Specialist who

  • Will be responsible for the daily execution of the Quality Management System (QMS).
  • Will work closely with quality and regulatory consultants.
  • Will work with Contract Manufacturers’ quality, including overseeing supplier quality audits.
  • Shares information and data that the leadership team informed and educated on quality and compliance concerns. 
  • Responds to all concerns with data driven and informed independence, and thorough action to assure the success of the company.

This is a remote or office with periodic travel position, and the scope of work will include: leading the document control, design control and risk analysis for ZiphyCare’s devices; build processes to make regulatory compliance as easy as possible for all participants, and that demonstrate a solid understanding of how to make safe and effective medical devices; and will provide expertise in the areas of compliance, quality assurance, design controls, risk management, regulatory compliance and submissions for medical devices.

Qualifications

  • Background with ISO 13485 and 21 CFR Part 820 required.
  • Background in mechanical, electronic or software engineering for medical devices. 
  • General understanding of Good Manufacturing Practices.
  • Strong communication skills with the ability to present results and recommendations.
  • Operate effectively within cross-functional teams globally.
  • Proven critical thinking skills and problem-solving ability.
  • Ability to balance theoretical knowledge with empirical results.
  • Must be able to provide solutions that reflect understanding the business objectives and cost implications.
  • Ability to prioritize multiple tasks.
  • Knowledge of and/or experience in regulated industries.

Education and/or Experience

  • Bachelor's degree in an engineering discipline.
  • 5+ years experience working as a member of the Quality Assurance team in support of a commercially available Class II medical device.
  • Internal and/or external auditing experience.
  • Experience with electro-mechanical, class II medical devices is preferred.

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