Sustaining Design Quality Engineering Manager
Core
Lead a team of Sustaining Design Quality Engineers to support Joint Repair products across their lifecycle, ensuring safety, effectiveness, and compliance.
Role type
Senior IC Quality Engineering Manager (Medical Devices)
Builds
Joint Repair medical device products
Domain
Medical Devices / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical device industry experience, FDA QSR knowledge, ISO 13485 knowledge, ISO 14971 knowledge, Design control management, Team leadership, Risk management, Regulatory submissions, DHF management, Gap analysis
Preferred skills
CQE certification, Lead Auditor certification
Technologies
FDA QSR, ISO 13485, ISO 14971
Responsibilities
Leading a team of Sustaining Design Quality Engineers, Driving product lifecycle management initiatives, Ensuring robust and compliant design control practices, Reviewing and approving key quality deliverables, Partnering with cross functional teams, Supporting regulatory submissions and audits, Leading DHF assessments and gap analyses, Providing technical leadership and mentorship, Influencing stakeholders and resolving complex challenges
Seniority
Senior, hands-on IC with strategic influence
