Head of Life Science
Quality Director – Medical Device Start-Up
We are seeking a Quality Director with strong strategic vision and leadership capabilities to join our executive team.
* Lead the development and execution of our Quality Management System (QMS) to ensure compliance with international standards and regulations.
* Partner closely with Operations, R&D, Regulatory Affairs, and Commercial teams to support product development, manufacturing, and market launch activities.
* Build and scale quality systems to match our growth trajectory, including internal and external auditing, supplier quality management, and CAPA systems.
* Develop and mentor a growing quality and regulatory team, fostering a culture of quality throughout the organization.
About You
* Minimum of 10 years' experience in Quality Assurance within the medical device industry, with at least 3 years in a leadership role.
* Deep knowledge of international medical device regulations and standards.
* Demonstrated ability to build, implement, and evolve scalable quality systems in a growing organization.
* Strategic thinker with strong leadership, communication, and team-building skills.
What's on Offer
* A senior leadership role with influence across the entire organization.
* Competitive salary, equity participation, and comprehensive benefits package.
Serviced as Senior Quality Leadership for Medical Devices Manufacturing Industry
Responsibilities include:
* ISO 13485:2016 Compliance Audits
* FDA 21 CFR 820
* MEDDEV2.7/B1 2004 Annex II