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Quality Engineer/Manager – Medical Device

  • Anywhere

Company :
Xtremity

Location :
Denver, Colorado

Expiry Date :
Wed, 23 Jun 2021 23:59:59 GMT

Apply Job :
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Description :
Our Mission: Restore mobility to every amputee.

You will be responsible for the implementation and management of the Companys Quality Management System (QMS), including for products on the market and new products in development. You will ensure the QMS meets regulatory requirements and will be the Companys point of contact with regulatory agencies for registration, submissions, and ongoing compliance. You will use your quality assurance background to ensure our quality standards extend to our vendors and partners, implement processes for receiving and inspecting parts to verify key specifications and functionality, and use a data driven approach to minimize quality issues and improve supply chain efficiency.

* Implement a Quality Management System based on ISO 13485 and 21 CFR 820 that meets regulatory requirements for a Class 2 Medical Device
* Provide management and oversight to the QMS once implemented for products on the market and new products in development
* Lead process validation and implement supplier agreements which ensure quality standards to extend to our partners and vendors
* Inspect, test, and sample materials or assembled parts or products for defects and deviations from specifications.
* Observe and monitor production operations and equipment to ensure conformance to specifications and make or order necessary process or assembly adjustments
* Discuss inspection results with those responsible for products; and recommend necessary corrective actions.
* Discard or reject products, materials, and equipment not meeting specifications
* Achieve quality goals through planning, coordinating, and supervising quality activities
* Oversee internal and external quality audits and review findings with management
* Maintain all controlled documents and revisions according to the QMS
* Maintain calibration standards on all relevant measurement and test equipment
* Develop corrective action plans for non-conforming product and develop process improvements
* Oversee day-to-day quality functions including inspecting the parts and processes

Requirements

* BS in Engineering or equivalent with 5+ years of related QA experience managing vendors within the medical device space
* Working knowledge of ISO 13485 and 21 CFR 820
* Experience working with the FDA, MHRA, MDA, and other regulatory agencies
* Experience with class 1 and 2 medical devices; prosthetics industry is a plus
* Strong communication and interpersonal skills building strong relationships with vendors
* Strong organizational skills and attention to detail

Benefits

Join our cutting-edge prosthetics device company!

We are a team who was brought together by our shared passion in trauma counseling for those living in war zones. Due to our common desire in finding a viable solution for amputees, we developed a best-in-class prosthetic device and now we are excited to join the for-profit world as an exciting new start-up to further evolve our device and share this technology globally.

We provide benefits to all employees, including stock options. Come and join our driven, talented and growing company! We are building a world-class company based in Denver.