12-Month QMS Integration Lead — Medical Devices

Korn Ferry

Zürich

On-site

CHF 140,000 - 200,000

Full time

6 days ago
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Job summary

Korn Ferry is seeking a QMS Integration Lead for a 12-month contract in Switzerland. The role focuses on assessing the current QMS landscape, defining the future-state model and leading the integration of quality processes, systems and governance across a complex medical device environment.

The candidate will define a structured gap assessment, develop a detailed integration roadmap and drive governance across Quality, Regulatory, Manufacturing, IT and other functions.

Qualifications

  • Significant QMS experience within a regulated medical device or life sciences environment.
  • Experience implementing, integrating or transforming Quality Management Systems.
  • Strong knowledge of ISO 13485 and QMS expectations.
  • Experience conducting QMS gap assessments and remediation/implementation planning.
  • Experience designing future-state quality processes, workflows and governance.
  • Experience working across Quality, Regulatory, Manufacturing, Engineering, Supply Chain and IT.

Responsibilities

  • Assess current QMS landscape and governance across processes, records and systems.
  • Define future-state QMS operating model aligned with medical device regulations.
  • Lead gap assessment and develop a detailed integration roadmap.
  • Coordinate non-conformance, document control, change control and training management.
  • Establish governance, roles and decision-making for each QMS workstream.
  • Facilitate workshops with key stakeholders and translate requirements into site processes.
  • Oversee migration of records and ensure compliance during transition.
  • Support interfaces with CAPA, complaints, risk management and validation.
  • Ensure traceability, documentation, and evidence to support implementation.
  • Collaborate with IT, QA, Regulatory, Manufacturing and Supply Chain teams.

Skills

Workshop facilitation
Stakeholder management
Process mapping
ISO 13485 knowledge
QMS implementation
Cross-functional collaboration

Education

Degree in Quality, Engineering, Science, Regulatory Affairs, Manufacturing or related discipline

Tools

EQMS/PLM platforms

Job description

Korn Ferry is seeking a QMS Integration Lead for a 12-month contract in Switzerland. The role focuses on assessing the current QMS landscape, defining the future-state model and leading the integration of quality processes, systems and governance across a complex medical device environment.

The candidate will define a structured gap assessment, develop a detailed integration roadmap and drive governance across Quality, Regulatory, Manufacturing, IT and other functions.

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