QMS integration Lead

Job Requirements or Tasks

• Assess the current Quality Management System, including existing processes, procedures, records, systems and governance arrangements.
• Define the future-state QMS operating model in alignment with corporate requirements and applicable medical device regulations.
• Conduct a structured gap assessment between the current quality-system environment and the required future state.
• Develop a detailed QMS integration roadmap covering activities, dependencies, priorities, risks, owners and implementation timelines.
• Lead integration of non-conformance, document control, change control and training-management processes.
• Ensure integration activities support continued compliance and do not disrupt essential manufacturing or quality operations.
• Establish governance, roles, responsibilities, approvals, escalation routes and decision-making authorities for each QMS workstream.
• Coordinate activities across Quality, Regulatory, Manufacturing, Engineering, Supply Chain, IT and other relevant functions.
• Facilitate process-mapping, gap-assessment and future-state design workshops with key stakeholders.
• Translate corporate QMS requirements into practical site-level processes and implementation plans.
• Work with process owners and subject matter experts to revise, create and approve controlled procedures, work instructions, templates and records.
• Ensure QMS integration decisions are appropriately documented and supported by objective evidence.

NC&CAPA Management

• Assess the existing non-conformance process and associated records.
• Define the future-state process for identifying, documenting, investigating, reviewing and closing non-conformances.
• Establish classifications, workflows, responsibilities, escalation routes and approval requirements.
• Ensure effective interfaces with CAPA, complaints, supplier quality, risk management and change control.
• Support migration or controlled transition of relevant open records into the future-state system.
• Establish reporting for non-conformance trends, ageing, closure and process effectiveness.

Document Control

• Assess the existing document hierarchy, document-control practices and controlled-document inventory.
• Define the future document structure, ownership model, review cycles and approval workflows.
• Determine which policies, procedures, work instructions, forms and records should be retained, revised, replaced, migrated or retired.
• Coordinate review, remediation and approval of controlled quality documentation.
• Support implementation of document-control workflows within the approved organisational platform.
• Ensure version control, effective-date management, periodic review, archival and legacy-document traceability.
• Support controlled retirement of obsolete or superseded documentation.

Change Control

• Assess the existing change-control process and identify compliance, governance and workflow gaps.
• Design and implement a future-state change-control process aligned with corporate QMS requirements.
• Define change categories, risk assessments, impact assessments, approvals and effectiveness checks.
• Ensure changes are assessed for impact on products, processes, equipment, facilities, suppliers, documentation, training and regulatory commitments.
• Establish interfaces with validation, regulatory affairs, document control, supplier quality and training.
• Support transition of open change records and confirm ownership through the integration period.
• Establish reporting and governance for open, overdue and high-risk changes.

Training Systems and Curricula

• Assess the existing quality training system, curricula, role profiles and training records.
• Define the future-state training governance model and associated responsibilities.
• Develop role-based curricula aligned with approved procedures, job responsibilities and regulated activities.
• Support implementation of the organisational electronic training-management system.
• Coordinate migration or reconciliation of appropriate training records.
• Establish processes for assigning, completing, monitoring and reporting required training.
• Ensure revised or newly approved QMS documentation triggers appropriate training requirements.
• Support assessment of training effectiveness where required.
• Provide implementation support to process owners and training administrators rather than delivering routine employee training.

Systems Implementation and Data Transition

• Support configuration and implementation of QMS processes within Agile or OnePLM or other approved organisational platforms.
• Translate business and quality-process requirements into clear system and workflow requirements.
• Work with IT, system administrators and vendors to support configuration, testing and deployment.
• Define user requirements and acceptance criteria for relevant QMS workflows.
• Support system validation and user acceptance testing where applicable.
• Ensure electronic records, approvals, audit trails and access controls meet regulatory and data-integrity requirements.
• Develop migration, reconciliation and verification plans for documents, training records and open quality records.
• Ensure legacy information remains appropriately retained, traceable and accessible.

Programme Management and Compliance

• Maintain a detailed QMS integration plan with clear milestones, dependencies and accountable owners.
• Identify and escalate risks affecting compliance, manufacturing continuity or the programme timeline.
• Provide regular progress reporting to programme and quality leadership.
• Track integration issues, decisions, actions and overdue deliverables.
• Establish measurable readiness and completion criteria for each QMS workstream.
• Support internal audits, mock inspections and integration-readiness assessments.
• Create objective evidence demonstrating that implemented processes are controlled and operating as intended.
• Support health checks and effectiveness reviews following implementation.
• Ensure the integrated QMS is scalable and capable of supporting planned increases in manufacturing activity.

Qualifications

Essential

• Degree in Quality, Engineering, Science, Regulatory Affairs, Manufacturing or a related technical discipline.
• Significant QMS experience within a regulated medical device or similarly controlled life sciences environment.
• Demonstrable experience implementing, integrating or transforming Quality Management Systems.
• Strong working knowledge of ISO 13485 and applicable medical device QMS expectations.
• Experience conducting QMS gap assessments and converting findings into structured remediation and implementation plans.
• Experience designing future-state quality processes, workflows, governance models and responsibilities.
• Strong understanding of controlled documentation, records management and document lifecycle requirements.
• Experience establishing or improving change-control processes in regulated manufacturing.
• Experience implementing role-based training curricula and electronic training-management processes.
• Experience with electronic Quality Management Systems or Product Lifecycle Management platforms.
• Ability to understand system requirements and workflows without needing to be a software developer or platform administrator.
• Experience supporting system testing, user acceptance testing and controlled implementation.
• Strong knowledge of quality risk management, data integrity and audit-trail expectations.
• Experience working across Quality, Regulatory, Manufacturing, Engineering, Supply Chain and IT.
• Strong workshop facilitation, stakeholder management and process-mapping skills.
• Ability to create clear procedures, implementation plans, governance structures and status reports.
• Ability to work independently within an evolving programme.
• Willingness to travel

About Korn Ferry

Korn Ferry unleashes potential in people, teams, and organizations. We work with our clients to design optimal organization structures, roles, and responsibilities. We help them hire the right people and advise them on how to reward and motivate their workforce while developing professionals as they navigate and advance their careers. To learn more, please visit Korn Ferry at www.Kornferry.com