VP Quality Assurance

Join a Life-Changing Medical Device Company! We are actively seeking a highly qualified VP of Quality Assurance to join our leadership team. This is a pivotal role for a consummate professional ready to establish a robust Quality Management System (QMS) and lead our QA activities. You will play a critical part in ensuring our active implantable devices meet the highest regulatory standards.

What you’ll do:

In this role, you will spearhead all QA activities, ensuring that development and production processes adhere to the utmost quality standards.

• QMS Leadership: Establish, manage, and maintain the company's Quality Management System (QMS) in compliance with ISO 13485 and FDA-QSR.
• Audit Management: Lead and manage external audits for CE, ISO 13485, and FDA regulatory bodies to ensure full organizational compliance.
• Strategic Oversight: Guide the QA team and oversee quality assurance for multi-disciplinary products, specifically focusing on implants.
• Cross-Functional Collaboration: Foster effective relationships with internal departments (R&D, Operations) and external partners to ensure quality alignment across the board.
• Process Excellence: Drive continuous improvement in development and production processes, ensuring meticulous attention to detail.

Requirements:

• Experience: Minimum 10 years of extensive experience in QA/QMS management within the Medical Device industry – Must.
• Domain Expertise: Specific focus on Implants (experience with Active Devices is highly preferred).
• Management: Minimum 2 years of leadership experience, with a proven ability to guide and inspire QA teams.
• Regulatory Knowledge: Proven track record in establishing/managing systems in compliance with ISO 13485 and demonstrated expertise in leading FDA/CE/ISO audits.
• Education: Academic credentials in Engineering, Life Sciences, Quality, or a related discipline.
• Skills: Superior organizational abilities, ability to work independently, and excellent cross-functional collaboration skills.
• Language: Fluent English (verbal and written) is essential.

Advantages:

• Experience with Active Implantable Medical Devices (AIMD).
• Lead Auditor certification.
• Experience building a QMS from scratch in a startup environment.

Perks:

• Opportunity to shape the quality culture of a company developing life-changing products.
• Work in a high-level multi-disciplinary environment.
• Competitive executive compensation package.

If you are a QA leader with a passion for excellence and a history of regulatory success, we want you on our team. 

Apply today and ensure quality where it matters most!