Quality Lead

Motif Neurotech

Houston, Texas, United States
On-site
10+ years medical device quality experience
Direct ownership of iso 13485 qms
Class ii or class iii device design controls
The role involves owning and continuously improving the quality management system for a first-in-class implantable neurostimulator

Job Summary

  • The role involves owning and continuously improving the quality management system for a first-in-class implantable neurostimulator.
  • Candidates must partner with engineering, clinical, regulatory, and manufacturing functions to ensure high-quality products reach patients.
  • The company offers unlimited PTO, medical/dental/vision insurance, and a 401k plan as part of their benefits package.

Matching Summary

The role involves owning and continuously improving the quality management system for a first-in-class implantable neurostimulator.

Skills & Requirements

Must-have

  • 10+ years medical device quality experience
  • Direct ownership of ISO 13485 QMS
  • Class II or Class III device design controls
  • FDA 21 CFR Part 820 knowledge
  • ISO 14971 risk management expertise
  • Onsite work in Houston Texas required

Nice-to-have

  • Experience scaling QMS in early stage companies
  • Background in IDE to clinical study phases
  • Supplier quality for electromechanical implants
  • Familiarity with IEC 62304 software standards
  • Sterile packaging quality requirements knowledge

Key Requirements

  • 10+ years progressive leadership in medical device quality
  • Direct ownership of ISO 13485 quality management system
  • Working knowledge of 21 CFR Part 820 and ISO 14971
  • Experience managing quality teams and cross-functional partnerships
  • Authorized to work in the United States without sponsorship

Work Rights

Must be authorized to work in the US

Tailored Resume

Cover Letter