Your Mission

As the Head of Quality, 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).