Medical Device Quality Assurance Specialist

5 days ago


Fort Mill, South Carolina, United States Jobot Full time

A rapidly growing Medical Device company is currently hiring for a Quality Assurance Specialist with Medical Device and ISO experience.

This is a fantastic opportunity for a Quality Assurance professional to join a dynamic team and contribute to the development and implementation of quality systems for medical devices.

Key Responsibilities:

  • Develop and implement quality systems and processes for medical devices
  • Conduct audits and inspections to ensure compliance with ISO standards and regulatory requirements
  • Collaborate with cross-functional teams to identify and mitigate quality risks
  • Develop and maintain quality documentation and records
  • Provide training and support to colleagues on quality systems and processes

Requirements:

  • 5+ years of experience in Quality Assurance specifically in the Medical Device Industry
  • ISO 13485 knowledge and experience with QSRs and GMPs for medical devices
  • Strong understanding of regulatory requirements and industry standards
  • Excellent communication and interpersonal skills
  • Ability to work in a fast-paced environment and prioritize multiple tasks

What We Offer:

  • Competitive salary range of $80,000 - $120,000 per year
  • 10% bonus
  • 401K with company match
  • Excellent opportunity for growth and professional development
  • Strong PTO and benefits package


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