Quality Systems Specialist
Job Summary
To support a growing hormonal health company, the remote Quality Systems Specialist will maintain the Quality Management System (QMS), conduct product compliance reviews, and train personnel on Standard Operating Procedures (SOPs) while ensuring adherence to quality system requirements.
Key responsibilities
- Oversee the maintenance and improvement of the QMS in compliance with relevant regulations
- Conduct product compliance assessments and support post-market surveillance activities
- Develop and conduct training sessions on QMS requirements and maintain training records
Required qualifications
- Bachelor's degree in Engineering, Life Sciences, Quality Management, Regulatory Affairs, or a related field
- Minimum 3+ years of experience in Quality Assurance, Quality Systems, or Regulatory Compliance in the IVD or Medical Device industry
- In-depth understanding of ISO 13485, FDA 21 CFR Part 820, and other regulatory requirements
- Experience with QMS software, document control systems, and audit processes
- Proven ability to manage multiple quality initiatives and implement process enhancements
Complete Job Description
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