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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Quality Business Partner - Medtech

Job Description