Vice President of Quality

Our client is a dynamic, growing leader in the medical device industry where patient outcomes and product excellence drive every decision. We are seeking a visionary, uncompromising Vice President, Quality to serve as the ultimate champion for product reliability and operational excellence across all North American sites.

In this pivotal role, you will provide end-to-end strategic leadership from initial concept and R&D through manufacturing, commercialisation, and post-market surveillance. Reporting directly to the NA President with a dotted line to the Global Head of Quality, you will harmonise regional quality management systems (QMS) with global frameworks, shifting quality from a compliance metric into a competitive business advantage.

• Quality Strategy & Culture:
  Define and execute the North American Quality strategy, embedding a culture of zero-defect engineering, continuous improvement, and total quality ownership across the organization.
• QMS Excellence:
  Implement, mature, and optimise global quality management systems and standards (FDA, ISO 13485, GMP) across NA manufacturing and distribution sites to guarantee the highest standards of safety and efficacy.
• Operational & Manufacturing Oversight:
  Partner with manufacturing and operations teams to monitor, measure, and elevate production quality metrics, ensuring absolute consistency and robustness in every process.
• Audit & CAPA Leadership:
  Lead internal and external regulatory audits, ensuring optimal preparedness, swift and thorough root-cause investigations of non-conformances, and the execution of robust CAPA frameworks.
• Lifecycle Quality Partnership:
  Collaborate closely with R&D, Operations, Commercial, and Service groups to embed quality-by-design principles, ensuring product reliability and structural risk mitigation from design to product sunset.
• Regulatory Alignment:
  Act as a critical technical advisor to regulatory affairs teams, ensuring that all submissions, 510(k) clearances, and post-market vigilance strategies are built upon flawless, defensible quality data.
• Team Stewardship:
  Mentor, guide, and inspire a matrixed regional Quality team, building advanced talent capability in statistical process control, risk management, and quality engineering.

• Experience:
  
  Minimum 15 years of experience in Quality management, including at least 10 years of senior leadership experience strictly within the medical device industry.
• Education:
  
  Bachelor’s degree in Engineering, Life Sciences, Biotechnology, or a related technical field. An advanced engineering or technical degree is strongly preferred.
• Technical Expertise:
  Comprehensive mastery of medical device quality standards (ISO 13485, FDA QSR, GMP) and a proven track record of designing, implementing, and measuring complex quality performance metrics.
• Soft Skills:
  
  Superior communication, critical thinking, and matrix-management capabilities. Must excel at advocating for quality principles across global, cross-functional teams and managing multi-time-zone coordination.
• Systems (Preferred):
  Familiarity with enterprise quality and manufacturing systems like SAP is a plus.