Job Description & How to Apply Below
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Role Description
The Quality Assurance Manager – R&D is responsible for establishing, implementing, and maintaining a robust Quality Management System (QMS) that meets the requirements of ISO 13485, ISO 27001, ISO 42001, MDSAP, and US Quality Management System Regulation and applicable global regulatory requirements. The Quality Assurance Manager – R&D shall also be the Management Representative for the company.
This position serves as the guardian of quality and compliance across the company, ensuring our medical device products—both hardware and SaMD—are developed, manufactured, and distributed in accordance with global regulatory standards.
This position also serves as the primary interface with external certification bodies, notified bodies, and regulatory authorities and will lead the transformation of our quality systems from paper-based processes to a modern electronic document management system while building a culture of quality, compliance, and continuous improvement throughout the organization.
Responsibilities
Quality Management System Implementation & Maintenance
Design, implement, and maintain an integrated Quality Management System that meets the requirements of ISO 13485, ISO 27001, ISO 42001, MDSAP, and United States QMSR as well as all relevant global regulatory requirements.
Ensure the QMS effectively addresses both hardware medical device and Software as a Medical Device (SaMD) requirements
Monitor and interpret new and emerging global quality and regulatory standards, regulations, and guidance documents
Assess impact of regulatory changes on the QMS and implement necessary updates to maintain compliance
Develop and maintain quality manuals, procedures, work instructions, and quality system documentation
Establish and oversee quality metrics and KPIs to measure QMS effectiveness and drive continuous improvement
Carry out the duties of the Management Representative as per ISO 13485, 5.5.2 and 21 CFR 820.20 (3)
Lead management review meetings and ensure top management visibility into quality system performance
Champion a culture of quality throughout the organization through training, communication, and leadership
Internal Audit Programs
Design and lead comprehensive internal audit programs covering all QMS processes and requirements
Develop risk-based audit schedules ensuring adequate coverage of all regulatory requirements
Manage execution of internal audits by providing training, guidance, and performance feedback to audit team.
Prepare detailed audit reports with objective evidence, findings, and improvement recommendations
Track audit findings to closure and verify effectiveness of corrective actions
Maintain audit records and documentation in compliance with regulatory requirements
External Audit Management
Serve as the primary point of contact for external certification bodies, notified bodies (EU MDR), and regulatory authorities (FDA, Health Canada, etc.)
Lead preparation activities for certification audits, surveillance audits, and regulatory inspections
Coordinate audit logistics, documentation reviews, and cross-functional audit response teams
Manage audit conduct, ensuring professional and compliant interactions with auditors and inspectors
Lead the resolution of audit findings, observations, and non-conformances within required time frames
Prepare and submit responses to certification bodies and regulatory agencies
Maintain ongoing communication with external bodies regarding compliance status and corrective actions
Ensure successful audit outcomes and…
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