VP Quality Assurance
The VP of Quality Assurance leads all QA activities at a medical device company, ensuring development and production processes meet the highest quality and regulatory standards (ISO 13485, FDA-QSR). This includes QMS leadership, audit management, strategic oversight, and cross-functional collaborati
About the role
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!
Frequently Asked Questions
What are the main responsibilities of the VP of Quality Assurance?
The VP of Quality Assurance is responsible for establishing and maintaining the company's Quality Management System (QMS), leading external audits, providing strategic oversight of QA activities, and fostering cross-functional collaboration to ensure quality across all departments.
What skills and experience are required for this VP of Quality Assurance role?
This role requires a minimum of 10 years of QA/QMS experience in the medical device industry, with a focus on implants. Strong leadership skills, regulatory knowledge (ISO 13485, FDA/CE/ISO audits), and excellent cross-functional collaboration skills are essential. Fluent English is also required.
What are the working conditions like for the VP of Quality Assurance?
This is an on-site, full-time position in Israel, offering the opportunity to shape the quality culture of a life-changing medical device company. You'll work in a high-level multi-disciplinary environment with a competitive executive compensation package.
Ready to apply?
Attach your CV and we’ll review your profile. If there’s a strong match, we’ll reach out.