Quality Manager

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

We are looking for a passionate Quality Manager to join our team at Sava! As the Quality Manager, you will be responsible for all quality activities - with a primary focus on implementing and maintaining an effective Quality Management System (QMS). Your role will be critical in ensuring compliance with industry regulations and standards, and in driving continuous improvement across all aspects of our organisation's quality processes.

The business is at a critical growth stage, and the successful candidate will work closely with our QA / RA Lead to push the business closer to launching our device. You’ll collaborate cross-functionally every day to build and improve processes to allow the business to operate in an efficient and compliant way.

We’re looking for someone who is self-sufficient, can easily determine what is required vs what is ‘nice to have’ and who can embed a quality mindset throughout the organisation.

• Review SAVA’s processes and implement a compliant, practical Quality Management System aligned with ISO 13485
• Collaborate cross-functionally to improve SAVA’s processes while maintaining compliance
• Lead the design and implementation of new procedures from scratch
• Manage the daily operation of the QMS
• Lead product and process change management from a QA perspective
• Achieve QMS certification to ISO 13485
• Promote the value of a solid QMS across the business
• Embed quality principles early in SAVA’s operations
• Develop junior staff members
• Lead QA recruitment activities

Experience:

• >5 years of quality assurance experience
• Experience in medical device industry, specifically new product development
• Professional certifications such as Certified Quality Manager (CQM), Certified Quality Auditor (CQA), or Certified Manager of Quality/Organisational Excellence (CMQ/OE) are a plus

Hard

Skills:

• Extensive knowledge of quality management principles, regulatory requirements (ISO 13485, FDA QSR), and industry best practices
• Ability to implement and maintain a QMS compliant with standards and regulations
• Proven ability to lead and manage audits and inspections
• Strong understanding of risk management principles and practices
• Strong understanding of product design verification and validation testing
• Strong analytical and problem‑solving skills with attention to detail

Soft Skills:

• Self-sufficient and proactive
• Excellent communication and interpersonal skills to collaborate across departments and levels
• Ability to work effectively with engineering and technical disciplines (Mechanical, Electronics, Bio Engineering)
• Elicit requirements from stakeholders
• Manage projects, time, resources, and timing plans

• Product / supplier QA experience
• Experience performing design verification and validation activities
• Experience using Confluence
• Professional certifications such as Certified Quality Manager (CQM), Certified Quality Auditor (CQA), or Certified Manager of Quality/Organisational Excellence (CMQ/OE)

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.