Senior Quality Strategist
About the Opportunity:
1. Purpose: Oversee the development and execution of a robust quality management system to ensure compliance with international standards and regulations.
2. Responsibilities:
* Collaborate with Operations, R&D, Regulatory Affairs, and Commercial teams to support product development, manufacturing, and market launch activities.
* Develop and implement scalable quality systems to match business growth, including internal and external auditing, supplier quality management, and CAPA systems.
* Mentor a growing quality and regulatory team, fostering a culture of excellence throughout the organization.
* Contribute to strategic decision-making as part of the senior leadership team, providing input on expansion initiatives and operational scale-up.
* Serve as primary liaison with regulatory bodies during inspections, audits, and certification processes.
About You:
* Minimum 10 years' experience in Quality Assurance within the medical device industry, with at least 3 years in a leadership role.
* Proven knowledge of international medical device regulations and standards.
* Demonstrated ability to design, implement, and evolve effective quality systems in a fast-paced environment.
* Strategic thinker with strong leadership, communication, and team-building skills.
* Ability to work effectively in an entrepreneurial setting.
* Desirable: Experience supporting product commercialization and operational expansion.
* Educational background in Engineering, Science, or a related technical field; advanced degree preferred.