Quality Business Partner - Medtech

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.
• #unipharmedtech

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