Overview
All the health information we need is within us. Just below the skin. Sava is redefining the way people interact with their health by developing the most advanced biosensing technology science has to offer, capable of accessing bodily information in a painless, real-time and affordable way.
About Sava
All the health information we need is within us. Just below the skin. Sava is redefining the way people interact with their health by developing the most advanced biosensing technology science has to offer, capable of accessing bodily information in a painless, real-time and affordable way.
The Role
At Sava, we’re building next-generation biosensors that demand not only bold innovation but also rigorous discipline. The Quality Assurance Coordinator role will support Sava's Operating System (formally Quality Management System) by coordinating quality activities, maintaining documentation and ensuring compliance with internal policies and applicable regulatory requirements.
You’ll join at a critical growth phase as we work towards ISO certifications and technical file submissions for regulatory approvals. You will work closely with the Quality Manager and QARA Lead to embed a culture of quality, compliance, risk management, data integrity, and continuous improvement across Sava.
What You\'ll Do
- Support operationalisation and maintenance of the ISO 13485 compliant Sava Operating System.
- Assist with Internal / External Audits and readiness activities.
- Create, review, format and control quality documentation (e.g. Templates).
- Maintain document control systems and versioning for company-wide and team-specific documentation.
- Support deviation, CAPA, nonconformance and complaint tracking and resolution.
- Monitor quality metrics and prepare reports / dashboards ahead of Management Review meetings with Top Management.
- Coordinate quality training programs and track completion.
- Lead on Employee onboarding to the Sava Operating System and ongoing quality education.
- Champion a company-wide culture of quality - where doing things properly is the default, not the exception.
- Act as a liaison between Quality and other Departments / Teams (e.g. Manufacturing) to ensure quality is embedded throughout the organisation.
What We\'re Looking For
- Bachelor’s degree in Life Sciences, Healthcare, Quality, Engineering or related field.
- 1-3 years experience in quality assurance, compliance or regulated operations.
- Experience in regulated environments (e.g. healthcare, biotech, pharmaceutical, digital health).
- Familiarity with quality systems SOPs and document control.
- Familiarity with 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.
- Some Audit and/or CAPA experience.
- Strong attention to detail and organisation skills.
- Excellent written and verbal communication skills.
- Problem-solving skills and mindset with a focus on continuous improvement.
- Comfortable working with cross-functional Stakeholders.
- Ability to manage multiple priorities and deadlines.
Bonus Points For
- Experience with continuous glucose monitoring (CGM) or similar medical device technologies.
- Experience with QMS or document management software.
- List in a bullet point format all benefits & perks the successful candidate will have access to
- Familiarity with start-up or scale-up company dynamics.
Why Sava?
This is a high-ownership, high-responsibility role in a company that’s building something complex, meaningful, and fast. The expectations are high, the learning curve is steep, and the work is often messy - but the impact is real. We don’t have room for egos or passengers. What we do have is a team of thoughtful, driven, and mission-aligned people who are committed to building something better—and doing it with urgency and integrity.
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