Adecco Lifescience is looking for a Quality Assurance Manager
Role DescriptionThe 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.
ResponsibilitiesQuality 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 timeframes
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 maintenance of certifications and regulatory clearances
Non-Conformance, CAPA & Complaint Management
Establish and manage robust processes for non-conformance identification, documentation, and resolution
Oversee the Corrective and Preventive Action (CAPA) system ensuring timely investigation and effective corrective actions
Ensure root cause analysis activities are conducted using structured methodologies (5 Why, Fishbone, Fault Tree Analysis)
Manage the complaint handling process in accordance with ISO 13485 and FDA QMSR and other applicable regulatory requirements
Ensure appropriate evaluation of complaints for reportability to relevant regulatory authorities
Monitor CAPA effectiveness and ensure corrective actions eliminate recurrence
Generate trending reports and analyses to identify systemic quality issues and provide data input into Post-Market Surveillance, PSURs, Risk Management Files as requested.
Interface with cross-functional teams to implement corrective actions across the organization
Good Manufacturing Practices & Good Documentation Practices
Establish and enforce Good Manufacturing Practices (GMP) across all MedTech AI functions & divisions
Implement and maintain Good Documentation Practices (GDP) including data integrity principles
Ensure compliance with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available)
Conduct regular assessments of manufacturing and documentation practices
Provide training and guidance on GMP and GDP requirements to all personnel
Develop and implement data integrity policies and controls for both paper and electronic systems
Monitor adherence to documentation standards and investigate deviations
Document Control & Records Management
Own and manage the document control system ensuring proper creation, review, approval, distribution, and archival of controlled documents
Establish document naming conventions, revision control, and version management processes
Ensure appropriate document retention periods are defined and maintained per regulatory requirements
Manage records throughout their lifecycle from creation through archival or destruction
Lead the transition from paper-based QMS to Electronic Document Management System (EDMS)
Select, implement, and validate EDMS ensuring 21 CFR Part 11 compliance for electronic records and signatures
Train personnel on document management processes and EDMS functionality
Ensure business continuity during the paper-to-electronic transition
Training & Competency Management
Develop quality and compliance training programs for all personnel
Ensure personnel receive appropriate training on QMS requirements, Good Manufacturing Practices, Good Documentation Practices, Information Security and relevant regulations
Maintain training records and competency assessments
Provide specialized training on audit processes, CAPA, and complaint handling
Physical RequirementsExpected travel is 30%
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