QMS integration Lead

We have partnered with our client in their search for a QMS Integration Lead on a 12-month initial contract
, supporting a significant Quality Management System integration and transformation programme. This is a hands‑on role focused on assessing the current QMS landscape, defining the future‑state model and leading the integration of quality processes, systems and governance across a complex, regulated medical device environment.

• 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.

• 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.

• 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.

• 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.
• Suppo…