About Mindlabs

Mindlabs develops connected temperature and environmental monitoring solutions for pharmaceutical, healthcare, food, logistics and enterprise customers. Our products combine sensors and electronics, embedded firmware, cellular/Wi-Fi connectivity, cloud software, calibration and customer-facing reports. The Quality Systems & Validation Lead will establish the processes and evidence needed to deliver these products consistently and support customers operating in regulated environments.

Role purpose

This is a hands-on, zero-to-one role responsible for building and operating Mindlabs' Quality Management System and validation framework. The role will lead ISO 9001 readiness, product and computer-system validation, CAPA and change control, audit preparation and customer validation support. The position will also coordinate SOC 2 readiness with external specialists and internal control owners; it is not a cybersecurity engineering role.

Key responsibilities

Quality Management System and ISO 9001
- Design, implement,



maintain and continually improve the QMS in line with ISO 9001 and business requirements.
- Own the quality manual, SOP hierarchy, formats, records, version control, retention and approval workflows.
- Establish and operate CAPA, deviations, nonconformities, change control, customer complaints and root-cause analysis.

Product and system validation
- Develop the validation strategy and Validation Master Plan for applicable products, software systems and customer use cases.
- Translate product and customer requirements into validation deliverables such as URS, functional/design specifications, risk assessments and acceptance criteria.
- Prepare or review validation plans, protocols and reports, including IQ/OQ/PQ where applicable.
- Maintain end-to-end traceability from requirements and risks to test cases, deviations, evidence and release decisions.
- Coordinate validation activities across hardware, firmware, mobile/web applications, cloud

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