Skills Alliance
Recruitment Consultant | Medical Devices QA United States & Europe
Role:
Vice President of Quality Assurance - Medical Devices (Class III Oncology) Employment Type:
Full-time Our client, an innovative medical technology company, is developing a groundbreaking Class III oncology detection device that has the potential to transform cancer diagnostics worldwide. We are seeking an accomplished Vice President of Quality Assurance to lead the QA function through late-stage development, regulatory approval, and commercialisation. Role Overview
The VP of Quality Assurance will be responsible for setting and driving the company’s global quality strategy, ensuring compliance with international regulatory standards (FDA, EMA, ISO 13485, MDSAP), and embedding a culture of quality across the organisation. This executive will build and scale the quality organisation, oversee design control processes, validation, risk management, and clinical quality systems, and partner closely with R&D, Regulatory Affairs, and Operations to ensure a successful product launch. Key Responsibilities
Lead, design, and implement the global Quality Management System (QMS) in compliance with ISO 13485, 21 CFR Part 820, MDSAP, and EU MDR. Provide executive oversight on all activities related to design controls, DHFs, DMRs, supplier quality, and CAPA systems. Ensure risk management processes are robust and aligned with ISO 14971 standards. Collaborate closely with R&D during product development to ensure validation, verification, and documentation standards are met. Prepare for and lead interactions with regulatory agencies, Notified Bodies, and external auditors. Build, manage, and mentor the QA team, establishing strong talent pipelines as the company scales. Serve as a strategic partner to the CEO, Board of Directors, and executive team in risk assessment and commercialisation readiness. What we are looking for
15+ years of progressive experience in Quality Assurance leadership within the medical device industry, with at least 1 - 2 years at the executive level. Deep expertise in bringing Class III medical devices to market, ideally with oncology, diagnostic, implantable, or other high-risk technologies. Proven track record overseeing design controls, validation, and global launches of novel devices. Extensive knowledge of FDA, EMA, and international device regulations, including ISO standards (ISO 13485, ISO 14971). Strong leadership, communication, and cross-functional influencing skills. Experience in high-growth, innovative environments where quality frameworks must be scaled rapidly. Seniority level
Executive Employment type
Full-time Job function
Quality Assurance Industries
Medical Equipment Manufacturing
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Role:
Vice President of Quality Assurance - Medical Devices (Class III Oncology) Employment Type:
Full-time Our client, an innovative medical technology company, is developing a groundbreaking Class III oncology detection device that has the potential to transform cancer diagnostics worldwide. We are seeking an accomplished Vice President of Quality Assurance to lead the QA function through late-stage development, regulatory approval, and commercialisation. Role Overview
The VP of Quality Assurance will be responsible for setting and driving the company’s global quality strategy, ensuring compliance with international regulatory standards (FDA, EMA, ISO 13485, MDSAP), and embedding a culture of quality across the organisation. This executive will build and scale the quality organisation, oversee design control processes, validation, risk management, and clinical quality systems, and partner closely with R&D, Regulatory Affairs, and Operations to ensure a successful product launch. Key Responsibilities
Lead, design, and implement the global Quality Management System (QMS) in compliance with ISO 13485, 21 CFR Part 820, MDSAP, and EU MDR. Provide executive oversight on all activities related to design controls, DHFs, DMRs, supplier quality, and CAPA systems. Ensure risk management processes are robust and aligned with ISO 14971 standards. Collaborate closely with R&D during product development to ensure validation, verification, and documentation standards are met. Prepare for and lead interactions with regulatory agencies, Notified Bodies, and external auditors. Build, manage, and mentor the QA team, establishing strong talent pipelines as the company scales. Serve as a strategic partner to the CEO, Board of Directors, and executive team in risk assessment and commercialisation readiness. What we are looking for
15+ years of progressive experience in Quality Assurance leadership within the medical device industry, with at least 1 - 2 years at the executive level. Deep expertise in bringing Class III medical devices to market, ideally with oncology, diagnostic, implantable, or other high-risk technologies. Proven track record overseeing design controls, validation, and global launches of novel devices. Extensive knowledge of FDA, EMA, and international device regulations, including ISO standards (ISO 13485, ISO 14971). Strong leadership, communication, and cross-functional influencing skills. Experience in high-growth, innovative environments where quality frameworks must be scaled rapidly. Seniority level
Executive Employment type
Full-time Job function
Quality Assurance Industries
Medical Equipment Manufacturing
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