Product Compliance & Quality Lead

Location: Hyderabad (UK-based candidates considered for the right profile)

Reports to: COO

Type: Full-time, permanent

Read this part first:

Quin makes sensor-and-software modules with a battery and a radio insid that get embedded into other brands' helmets and PPE.

That means we are an ingredient brand, and we own obligations at the component and radio level: our radio module's conformity, our battery, our substance declarations, our producer registrations, and the evidence pack our partners rely on when they place a finished product on the market. We also own the CE mark on our product while our partners own the finished combined-product CE mark and the certifications specific to their product category.

We are not a medical device company. If your background is pharma QA, GxP, or medical-device regulatory 21 CFR 820, ISO 13485, 510(k), MDR this is not a lateral move, and we would rather tell you that now than after a screen.

What you'll own:

You are the first and, for a while, the only compliance and quality hire. Nobody hands you a system. You build it.

Regulatory scope and market access:

Determine what applies to our modules and where. Own the Radio Equipment Directive route, EMC and RF conformity, FCC/ISED equivalents for the US, and the full battery picture UN 38.3 for transport, IEC 62133 for cell and pack safety, and EU Regulation 2023/1542 including the obligations that bite at design time, not at launch.

Technical files and declarations:

Author and maintain our technical documentation. Own the Declaration of Conformity. Manage notified body and test lab relationships directly.

Materials and producer responsibility:

RoHS and REACH substance compliance across the BOM. WEEE, battery, and packaging EPR registrations in the markets we sell into, plus India's E-Waste and Battery Waste Management Rules.

A quality system from zero:

Design and stand up a QMS proportionate to our size and risk document control, change control, design records, nonconformance and CAPA, supplier controls. Fit for purpose, not ceremonial. We want a system a team of fifteen will actually use.

Supplier and contract manufacturer quality:

We don't own our manufacturing. You'll qualify and audit CMs, set incoming quality requirements, drive defects to closure with real data, and prove fixes held.

Partner enablement:

Our partners need to certify finished products that contain our module. You'll build the documentation, test evidence, and guidance that lets them do that without a call every time and you'll be the person they escalate to when they hit something new.

What we're actually looking for:

The complete stack connected-hardware regulatory, QMS-from-scratch, and contract manufacturer quality rarely sits in one person. We're looking for strength in two of those three and clear evidence you can close the third.

What we won't compromise on:

- You've owned compliance from the manufacturer's side, not only assessed it from a test lab or certification body. Lab and notified body experience is genuinely valuable but we need someone who has been accountable for a product shipping, not for a report being issued.

- You've worked on connected, battery-powered hardware. Radios and cells, not just electronics.

- You can tell the difference between what we owe and what our partners owe, and you don't blur it under schedule pressure.

- You default to action. You'll frequently have partial information and a launch date. We'd rather you make a defensible call, write down the assumption, and revisit it than wait for certainty.

Useful signals, none of them mandatory:

- Type approval or homologation experience.

- EMC/RF pre-compliance and design review.

- ISO 9001 implementation.

- IEC 62368-1; EN 1078 or PPE Regulation 2016/425 exposure.

- Managing suppliers in China or India.

How this role is set up to work:

You will not be expected to be world-class at every regulation touching this product. Nobody is.

We hold a budget for specialist advisors battery safety, RF pre-compliance, EU battery regulation and EPR and you'll have authority to engage them. Knowing when to bring in a specialist, and scoping the question well, is part of the job rather than an admission of a gap.

A Compliance Engineer will join to work alongside you once you've had time to set direction. You'll help define that role and hire into it.