Packaging/medical Device Quality Specialist

Seqirus

Not specified
Quality assurance
Regulatory compliance
Design controls
Seqirus is seeking a Packaging/Medical Device Quality Specialist to ensure compliance with global regulations in the development of combination products and medical devices. The ideal candidate will have experience in quality assurance within the medical device sector and strong knowledge of relevant regulatory requirements

Job Summary

  • The Packaging/Medical Device Quality Specialist ensures compliance with FDA, EU MDR, and ISO standards throughout the product lifecycle.
  • This role involves working with global teams to develop and maintain a compliant quality system for combination products.
  • The position offers opportunities to contribute to innovative medical device projects and collaborate with cross-functional teams.

Matching Summary

Match Score: 85

Seqirus is seeking a Packaging/Medical Device Quality Specialist to ensure compliance with global regulations in the development of combination products and medical devices. The ideal candidate will have experience in quality assurance within the medical device sector and strong knowledge of relevant regulatory requirements.

Skills & Requirements

Must-have

  • Quality Assurance
  • Regulatory Compliance
  • Design Controls
  • Risk Management
  • Medical Device Standards
  • Global Regulatory Requirements

Nice-to-have

  • Drug-Delivery Systems
  • Embedded Software
  • Connected Health Solutions

Key Requirements

  • Bachelor's degree in relevant field
  • Minimum 3 years of experience
  • Experience in medical device R&D Quality
  • Knowledge of 21 CFR Part 4, FDA, and EU MDR regulations

Work Rights

Not specified

Tailored Resume

Cover Letter