Job Description

Responsibilities

• Act as a Quality subject matter expert (SME) across all MedTech teams.

• Act as a point of contact for all quality matters across EU Medtech business.

• Work closely with business and/or Third-Party teams to provide expert quality information and support continuous improvement.

• Provide proactive Quality input into new business models.

• Evaluates, and/or reviews procedures and other activities in support of an integrated, cross functional QMS.

• Fosters a commitment to quality in individuals and a culture of quality across the MedTech business.

• Facilitates effective communication and knowledge sharing across teams to promote a culture of quality.

• Ensures rapid communication of quality issues and risks to appropriate management and leaders.

• Ensures rapid communication of quality issues and risks including potential misconduct to appropriate leaders and colleagues.

• Support with the management of intercompany agreements and quality agreements.

• Support with deviation investigations and CAPAs.

• Support with the raising of change controls and risk assessments.

• Ensure distribution and product compliance.

• Provide guidance on MDR and supplier oversight.

• Support audit readiness.

• Partner with cross-functional teams.

• Drive continuous improvement initiatives.

• Promote a proactive quality culture.

• Support development of quality KPIs and reporting.

• Quality Questionnaire / tender support

Essential

• Minimum 3 years’ experience in Medical Devices, MedTech or Pharma distribution

• Strong working knowledge of ISO 13485, MDR requirements, and distribution regulations (e.g., WDA)

• Experience in QMS processes, audits, CAPA, deviations, and supplier management.

• Excellent communication, influencing and stakeholder‑engagement skills.

• Strong analytical, problem‑solving, and organisational abilities.

• Clean drivers licence and ability to travel. Travel across sites in both the domestic and European regions may be required.

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