Our client is a leading global company based in the Canton of Vaud, Switzerland, specializing in the development of high-precision medical devices.
With a strong focus on innovation, quality excellence, and regulatory compliance, the company is committed to advancing patient care through cutting-edge technologies. They have built a reputation as a trusted partner for healthcare professionals worldwide and continue to drive growth across international markets.
As part of their expansion, they are looking for a Head of Quality to further strengthen their operations and continue to ensure the delivery of high-quality, compliant medical devices.
Your Mission
As the Head of Quality & Regulatory Affairs, you will:
* Lead with Purpose: Be the driving force behind the strategic development and execution of the Quality Policy and Management System, aligned with ISO 13485, FDA QSR 21 CFR 820, and other global standards.
* Ensure Excellence: Spearhead quality assurance for product development, manufacturing, and market release while maintaining compliance with regulatory requirements.
* Shape the Future: Develop and implement strategies to uphold the reputation for product reliability as new products are launched and the company expands into new regions.
* Inspire and Motivate: Lead, mentor, and grow a high-performing quality team to meet the company’s ambitious goals.
Key Responsibilities
Strategic Leadership
* Act as the Management Representative and Person Responsible for Regulatory Compliance (PRRC), ensuring robust quality systems and regulatory adherence.
* Collaborate with cross-functional teams to support the seamless launch of new products and geographic expansion.
* Define and implement a forward-thinking regulatory strategy to support business growth across all units.
Operational Excellence
* Establish and enhance quality systems, ensuring continuous improvement and alignment with global standards.
* Manage third-party audits (ISO, FDA) and lead internal and supplier quality audits.
* Oversee product compliance, risk management, and supplier validation to ensure product reliability and customer satisfaction.
Team Development
* Lead and inspire the quality team, fostering a culture of accountability, innovation, and excellence.
* Provide training and promote regulatory awareness across the organization to build quality-conscious teams.
Performance Management
* Analyze quality-related data, oversee non-conformity resolutions, and drive corrective actions to improve product quality and minimize costs.
* Report on key performance indicators (KPIs) and present findings to top management.
Customer and Market Focus
* Partner with internal stakeholders to address client quality concerns and ensure post-market surveillance compliance.
* Support global growth by facilitating quality systems for new warehouses and country launches.
What We’re Looking For:
* Proven experience in quality management within the medical device industry or a regulated healthcare environment.
* Expertise in ISO 13485, FDA regulations, and risk management methodologies.
* Strong leadership skills, with a history of building and inspiring high-performing teams.
* Strategic thinker with a hands-on approach to problem-solving and process improvement.
* Exceptional communication skills and the ability to collaborate across diverse teams and functions.
* Academic background: Master’s degree or engineering qualification in a relevant field (e.g., engineering, quality management, life sciences, or similar).
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