13 Aug
|
Stellaspire
|
Hyderabad
13 Aug
Stellaspire
Hyderabad
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 inside — 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, no
📌 Product Compliance (Hyderabad)
🏢 Stellaspire
📍 Hyderabad