Quality Management Lead
- Oversee the development of Sava’s Quality Management System (QMS), ensuring alignment with ISO 13485, FDA, MDR, and other applicable standards.
- Translate complex quality and compliance requirements into simple, clear processes that empower Teams to move fast and right.
- Establish and monitor company-wide quality metrics, including manufacturing performance, Supplier quality, design controls, CAPA, training, and post-market surveillance.
- Present clear, actionable insights to Top Management and the Board to drive decision-making and continuous improvement.
- Partner with Suppliers to ensure materials and processes meet our standards.
- Build and mentor a high-performing Quality & Regulatory team.
- Champion a company-wide culture of quality - where doing things properly is the default, not the exception.
- Work cross-functionally with Operations, Product, Engineering, Manufacturing, Clinical and Regulatory Teams to ensure quality is embedded throughout workflows.
- Support the scale-up of wider Quality and Compliance processes to meet ISO 27001, GDPR, HIPPA, SOC II and other relevant frameworks.
- Expand Quality as a core company-wide function responsible for not just the QMS but Quality within each Department (e.g. QA Engineers in Manufacturing conducting Quality Control processes).
- Develop and deliver quality training programs for Employees, fostering a culture of accountability, quality awareness and continuous improvement.
- Degree in Quality, Engineering, Life Sciences, Healthcare, Business or a related field.
- 10+ years of experience in quality management, compliance or regulated environments, preferably in a product development, medtech, biotech or highly regulated hardware software environment.
- Experience with Quality Management Software and documentation systems, and a track record of building and scaling a QMS across R&D and manufacturing..
- Strong knowledge of quality management principles, regulatory requirements (such as ISO 13485, FDA QSR) and industry best practices.
- Familiarity with international regulations and standards, including but not limited to EU MDR, UK MDR, USA 510k, Health Canada regulations, and other regional regulatory requirements.
- Proven experience leading and managing audits and regulatory inspections.
- Strong analytical skills, with experience establishing and using quality metrics to drive decisions.
- Leadership style that is clear, pragmatic, and inspiring - you build systems, but more importantly, you build belief.
- Excellent communication and interpersonal skills across departments and all levels of the organisation.
- Excellent understanding of risk management principles and practices.
- Problem-solving skills and mindset with a focus on continuous improvement.
- Strong organisation and project management skills.
- Experience with continuous glucose monitoring (CGM) or similar device technologies.
- Background in both Separate (App) and Embedded (Reader) software-based product compliance.
- Familiarity with start-up or scale-up company dynamics.
- Professional certifications such as Certified Quality Manager (CQM), Certified Quality Auditor (CQA), or Certified Manager of Quality/Organisational Excellence (CMQ/OE) are a plus.
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