Quality System Manager

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 services, communication workflows and generated reports.
• Apply risk-based Computer System Validation/Computer Software Assurance principles appropriate to GxP customer environments.
• Evaluate software and product changes for validation impact and ensure required regression or revalidation activities are completed.

Data integrity and regulated-customer requirements

• Support alignment with applicable expectations such as GAMP 5, 21 CFR Part 11, electronic records, audit trails and ALCOA+ data-integrity principles.
• Review user access, audit-trail, time synchronization, backup, data retention and report-generation controls from a validation perspective.
• Prepare customer-facing validation packages and respond to QA, CSV and procurement questionnaires.
• Support customers with validation planning, protocol review, deployment qualification and documented acceptance where contractually required.

Audits and customer assurance

• Act as the primary coordinator for ISO, customer and partner quality audits.
• Maintain continuous audit readiness and ensure evidence is current, complete, approved and retrievable.
• Coordinate audit responses, root-cause analysis, corrective actions and closure evidence.
• Support sales and customer-success teams during technical-quality discussions without overstating product certifications or compliance claims.

Required qualifications and experience

• Bachelor's degree in engineering, pharmacy, life sciences, computer science, instrumentation or a related discipline.
• 2-4 years of relevant experience in quality systems, product/software validation, CSV, design quality or regulated product compliance.
• Hands-on experience with QMS processes such as document control, CAPA, deviations, change control, complaints, internal audits and management review.
• Working knowledge of ISO 9001 and experience supporting implementation, certification or surveillance audits.
• Experience preparing and executing validation lifecycle documents such as plans, requirements, risk assessments, protocols, traceability matrices and reports.
• Ability to independently build processes, obtain cross-functional inputs and follow actions through to closure.
• Strong written communication and the ability to create clear, inspection-ready documentation.

Why join Mindlabs

• Build a quality and validation function from the ground up rather than maintaining only one narrow part of an established system.
• Work across connected hardware, firmware, cloud software and real customer deployments.
• Gain direct exposure to leadership, product decisions and regulated enterprise customers.
• Create systems that influence product reliability, customer trust and business growth.