Sterile Medical Device Quality Expert
3 weeks ago
Spirair, Inc. is a cutting-edge medical device company that has revolutionized the way we approach healthcare. As a Quality Engineer at Spirair, you will play a critical role in ensuring the highest standards of quality and regulatory compliance in our products.
About the JobThis is a unique opportunity to join a dynamic team and contribute to the development of innovative medical devices. Your primary responsibility will be to support Spirair's Quality Management System, collaborating with the R&D and Operations teams to ensure seamless product development and manufacturing processes.
- Implement document control procedures, ensuring timely routing, approval, and release of documents.
- Lead investigative efforts into customer complaints, tracking returned materials, and identifying root causes.
- Collaborate with cross-functional teams to develop quality plans, participate in risk management, and conduct supplier audits.
- Maintain accurate records of supplier performance, adhering to FDA QSRs and ISO 13485 standards.
To succeed in this role, you should have:
- 5+ years of experience in quality engineering for medical device manufacturers.
- A solid understanding of FDA regulations and industry standards.
- Excellent communication and problem-solving skills.
- A collaborative mindset and ability to work effectively in a fast-paced environment.
Spirair offers an attractive compensation package, including a base salary of $130,000 and opportunities for growth and professional development.
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