VP of Quality
New
Remote-first flexibility across Canada and the US (NYC preferred)Full-TimeVp
Salary260,000 - 300,000 USD per year
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Job Details
- Experience
- 10+ years
Requirements
- 10+ years of progressive experience in quality leadership within the medical device industry.
- Demonstrated ownership or co-ownership of multiple ISO 13485 certifications.
- Proven experience building or transforming a QMS from the ground up.
- Strong understanding of regulatory frameworks: ISO 13485, ISO 14971, IEC 62304, and FDA 21 CFR Part 820.
- Experience spanning hardware, software, systems, and supplier quality.
- Track record of building and leading quality teams, including hiring and mentoring.
- Strong communication and stakeholder management skills to influence engineering and executive audiences.
Responsibilities
- Own the ISO 13485 certification roadmap, including gap assessment, QMS design, implementation, and successful audit completion.
- Architect and scale the Quality Management System within a PLM-integrated environment.
- Establish and continuously improve core QMS processes including document control, CAPA, internal audits, complaint handling, risk management, and post-market surveillance.
- Define and enforce quality standards across hardware, software, and electromechanical systems (ISO 14971, IEC 62304, FDA 21 CFR Part 820).
- Build and lead supplier and manufacturing quality systems, including audits, qualification frameworks, and Six Sigma-driven continuous improvement.
- Drive customer-facing quality resolution processes and act as escalation point for product quality issues.
- Build and mentor a high-performing quality organization.
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