Quality Management Lead

Story Terrace Inc.; Greater London; On-site; GBP 70,000 - 90,000; Full time

Job summary

A leading health technology firm in Greater London is seeking a Quality Management Lead to oversee the development and implementation of a robust Quality Management System. You will ensure that products meet internal standards and regulatory requirements while working cross-functionally to foster a quality-driven culture. The ideal candidate has over 10 years of experience in quality management or compliance in regulated environments, strong analytical skills, and exceptional communication abilities. This is an opportunity to make a significant impact on the organization's growth and stability.

Qualifications

• 10+ years of experience in quality management within regulated environments.
• Strong knowledge of ISO standards and regulatory requirements.
• Excellent communication skills and ability to lead cross-functional teams.

Responsibilities

• Oversee the development of the Quality Management System (QMS).
• Translate quality requirements into clear processes for teams.
• Establish and monitor company-wide quality metrics.

Skills

Quality management

Regulatory compliance

Risk management

Analytical skills

Project management

Education

Degree in Quality, Engineering, Life Sciences, or related field

Tools

Quality Management Software

Job description

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. As Quality Management Lead, you’ll set the standard for how quality and compliance enable us to grow responsibly and sustainably.

This role will ensure that products, services and processes consistently meet internal quality standards, regulatory requirements and Customer expectations.

You’ll join at a critical growth phase as we work towards ISO certifications and technical file submissions for regulatory approvals. You will partner cross-functionally to embed a culture of quality, risk management and continuous improvement across Sava.

If you’re ready to prove that Quality and Compliance can accelerate Go-To-Market success, this might be the right fit for you.

What You’ll Do

This role spans the full scope of Quality and Compliance leadership, defining strategy, navigating ISO certifications, owning company-wide quality metrics, and developing the Team that makes it all happen.

• 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.

What We’re Looking For

• 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.

Bonus Points For

• 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.

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.