Overview: Dozee Health AI is a pioneer in Contactless Remote Patient Monitoring (RPM), proven to drive transformation at scale. Headquartered in Bengaluru, India, Dozee has emerged as India’s no. 1 RPM Company.
We are seeking visionary individuals to help us in this very exciting journey. As a part of our dynamic team, you’ll have the opportunity to collaborate with top healthcare providers in the country, applying AI-powered RPM solutions to tackle some of the most pressing challenges in healthcare - enhancing staff efficiency, improving patient outcomes, and pioneering the next generation of care models.
Responsibilities
Plan, establish, implement, maintain, and continuously improve the Quality Management System (QMS) in accordance with EN ISO 13485 and applicable medical device regulatory requirements.
Drive QMS streamlining and process improvements across functions to ensure effective, efficient, and compliant quality processes throughout the product lifecycle.
Develop, review, and maintain quality policies, procedures, SOPs, work instructions, forms, and quality records in alignment with regulatory and organizational requirements.
Ensure effective implementation and maintenance of Design Controls, Document Control, Change Control, Risk Management, CAPA, Non-Conformance, Complaint Handling, Supplier Quality, Training, and other QMS processes.
Support regulatory compliance with applicable standards and regulations, including US FDA, EU MDR/CE Marking, CDSCO, IEC 60601, IEC 62304, ISO 14971, and other relevant requirements.
Prepare and maintain regulatory dossiers, Device Master Files/Technical Documentation, and quality-related documentation required for regulatory submissions and product lifecycle activities.
Work closely with Product Development, Product Transfer, Manufacturing, Engineering, and other cross-functional teams to ensure QMS and regulatory requirements are effectively implemented.
Provide guidance to cross-functional teams on quality and regulatory requirements at various stages of the medical device product lifecycle.
Conduct or support internal audits, supplier audits, Notified Body audits, and regulatory inspections, including audit preparation, coordination, response, and closure of observations/findings.
Lead the identification, investigation, implementation, and effectiveness verification of CAPAs and corrective/preventive actions.
Coordinate Management Review meetings, including preparation of quality metrics, performance indicators, inputs, action items, and follow-up activities.
Establish and monitor quality objectives, KPIs, and quality metrics to evaluate QMS effectiveness and identify opportunities for improvement.
Support supplier qualification, evaluation, monitoring, and supplier audits in accordance with established quality procedures.
Drive compliance with Good Documentation Practices (GDP) and ensure appropriate control, traceability, accuracy, and integrity of quality records.
Develop and deliver QMS and regulatory training and ensure employee awareness and compliance with applicable company policies, procedures, standards, and regulatory requirements.
Monitor changes in medical device regulations, standards, and regulatory guidance and assess their impact on the organization's QMS and products.
Support regulatory compliance assessments and gap assessments and coordinate implementation of required actions.
Ensure effective implementation of QMS processes, regulatory requirements, and quality commitments across the organization.
Identify opportunities for continuous improvement, process optimization, and QMS maturity enhancement through data-driven analysis, audit findings, CAPA trends, and management review outputs.
Maintain readiness for regulatory inspections and third-party audits and support timely and effective closure of audit observations.
Provide subject-matter expertise and guidance on QMS, quality assurance, regulatory compliance, and applicable medical device standards.
Requirements
B.Tech or equivalent educational qualification.
3-5 years of experience in Medical Device Quality Assurance, Quality Management Systems, and/or Regulatory Affairs.
Hands-on or working knowledge of QMS implementation, streamlining, improvement, maintenance, and compliance in accordance with ISO 13485.
Experience in developing, implementing, reviewing, and maintaining QMS procedures, SOPs, work instructions, and quality records.
Working knowledge of Design Controls, CAPA, Change Control, Document Control, Non-Conformance, Risk Management, Supplier Quality, Training, Complaint Handling, and other core QMS processes.
Knowledge of US FDA, EU MDR/CE Marking, CDSCO, ISO 13485, ISO 14971, IEC 62304, IEC 60601, and other applicable medical device regulations and standards.
Experience supporting regulatory submissions, new medical device registrations, and maintenance of regulatory/technical documentation.
Experience supporting regulatory inspections, Notified Body audits, internal audits, and supplier audits, including preparation and closure of findings.
Ability to analyze and interpret regulations, standards, guidance documents, technical procedures, and regulatory requirements and translate them into practical QMS processes.
Experience in quality metrics, Management Review, CAPA effectiveness, audit readiness, and continuous improvement initiatives.
Working knowledge of Good Documentation Practices and quality documentation management.
Ability to collaborate effectively with cross-functional teams throughout the medical device product development and product transfer lifecycle.
Strong analytical, organizational, problem-solving, and process-improvement skills.
Ability to work independently while effectively collaborating with different departments and stakeholders.
Strong leadership, communication, interpersonal, project management, and time-management skills.
Highly organized, process-oriented, detail-oriented, and committed to maintaining quality, compliance, and continuous improvement.
