Vice President of Quality

Weber & Company; Massachusetts; On-site; USD 210,000 - 320,000; Full time

Job summary

Weber & Company seeks a visionary Vice President, Quality to champion product reliability and operational excellence across North American sites in the medical device sector. Reporting to the NA President and Global Head of Quality, you will align QMS with global standards, lead audits and CAPA, and drive quality as a competitive advantage from design through post-market.

The role requires 15+ years in quality with 10+ in senior leadership, a bachelor’s in engineering or life sciences, and a

Qualifications

• 15+ years in Quality management, including senior leadership within medical devices.
• Experience leading quality strategy across concept to post-market.
• Strong knowledge of ISO 13485, FDA QSR, GMP.
• Excellent communication and cross-functional influence across global teams.

Responsibilities

• Define and execute NA Quality strategy and culture.
• Lead QMS implementation, maturation, and alignment with global frameworks (FDA/ISO 13485/GMP).
• Oversee regulatory audits, CAPA, and continuous improvement initiatives.
• Partner with R&D, Operations, and Commercial teams to embed quality-by-design.
• Mentor regional Quality teams and drive multi-time-zone coordination.

Skills

Quality leadership

Regulatory knowledge

Cross-functional leadership

Matrix management

Statistical process control

Education

Bachelor’s degree in Engineering or Life Sciences

Advanced engineering or technical degree preferred

Tools

SAP

Job description

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.

Key Responsibilities

• 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.

Requirements

• 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.