Supplier Quality Engineering Lead

Mission

Neko is redefining what prevention means, from treating illness when it arrives, to sustaining health before it's ever at risk. Our mission: make data-driven, preventative care accessible to more people, before symptoms appear.

In a single, non-invasive visit under an hour, proprietary technology and direct clinical care combine to deliver personalised, actionable insights. It's a team that thinks in 10x, not 10%. Every role here plays a part in building a world where prevention is the norm, and where your work genuinely helps people live longer, healthier lives.

ROLE PURPOSE

As a Supplier Quality Engineering Lead, you will own the supplier quality domain within Neko’s Operations QA function – building and maintaining the qualification frameworks, supplier audit programmes, and monitoring systems that ensure our supplier base meets Neko’s requirements as a medical device manufacturer operating in clinical and laboratory environments.

Your remit spans physical product suppliers and software and service suppliers across equipment, components, reagents, lab services, and manufacturing-related services. You will qualify suppliers, negotiate quality agreements, conduct audits, and manage nonconformities through to closure.

What makes this role distinct is its clinical and laboratory dimension. Neko’s products operate in clinical and diagnostic environments, and the suppliers in scope must meet the standards those environments impose – on top of ISO 13485, MDR, and IVDR. Experience qualifying suppliers who serve labs and clinics translates directly here.

This is a hands-on role within the Operations QA function. You will partner closely with engineering, manufacturing, procurement, regulatory affairs, and legal to deliver supplier quality outcomes that are credible to regulators and practical for the business.

WHAT YOU’LL DELIVER IN THE FIRST 6–12 MONTHS

• Audit and refresh the approved supplier list – review qualification status, re-evaluation dates, and quality agreement coverage for all active suppliers across physical product and software and service categories.

• Build a structured supplier audit program for critical and clinic/lab-facing suppliers, with protocols and checklists aligned to ISO 13485, ISO 15189, IVDR, and applicable regulatory requirements.

• Establish or strengthen quality agreement templates for lab equipment, diagnostic device, reagent, and service suppliers – covering change notification, calibration traceability, right-to-audit, SCAR obligations, and complaint handling.

• Define and implement supplier KPIs and a re-evaluation cadence that gives real visibility into supplier performance across the portfolio.

• Build qualification packages for new suppliers identified through product development and clinical expansion activities.

MINIMUM QUALIFICATIONS

• Relevant academic background (life sciences, engineering, or equivalent) or demonstrable equivalent experience.

• 5+ years of experience in supplier quality or quality assurance within a regulated industry (medical devices or diagnostics preferred).

• Working knowledge of ISO 13485:2016 supplier management requirements and ISO 15189 or equivalent clinical or laboratory quality standards.

• Hands-on experience planning and conducting supplier audits and negotiating quality agreements with critical suppliers.

• Familiarity with MDR (EU) 2017/745 and/or IVDR (EU) 2017/746 traceability and critical subcontractor obligations.

• Strong judgment: knows when to apply rigour and when pragmatism serves quality better; comfortable making decisions in a fast-moving environment.

• Fluent written and spoken English.

PREFERRED

• Direct experience qualifying suppliers of lab equipment, diagnostic analyzers, reagents, consumables, or clinical services – familiarity with ISO 15189, ISO 22870, IEC 61010, and CAP/CLIA is a plus.

• Familiarity with NBOG BPG 2010-1 critical subcontractor obligations under MDR and IVDR.

• Familiarity with 21 CFR Part 820 / QMSR.

• Experience with AI/ML-assisted quality tools or automated process improvements.

• Experience in fast-scaling organizations with evolving processes.

About titles at Neko

We use a simplified internal title framework that prioritises clarity over hierarchy, so internal titles may differ from market‑facing role titles. Scope, impact and level of the role are fully aligned and will be clearly discussed throughout the process.

Hiring Process

Candidates progress from application and structured screening through thoughtfully designed interviews culminating in a formal offer and final pre-employment checks before joining the team.

Equal Opportunity & Inclusion Statement

Neko Health is committed to inclusive hiring and member-first care. We welcome candidates from all backgrounds and encourage you to request reasonable adjustments to support your application.