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 settings.

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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