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Quality Business Partner - Medtech
Posted 4 days 8 hours ago by Unipharmedtech
Permanent
Full Time
Other
Not Specified, Ireland
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 the 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.
- Evaluate and/or review procedures and other activities in support of an integrated, cross functional QMS.
- Foster a commitment to quality in individuals and a culture of quality across the MedTech business.
- Facilitate effective communication and knowledge sharing across teams to promote a culture of quality.
- Ensure rapid communication of quality issues and risks to appropriate management and leaders, including potential misconduct.
- Support the management of inter company agreements and quality agreements.
- Support deviation investigations and CAPAs.
- Support 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.
- Provide support for quality questionnaire and tender processes.
- Minimum: 3 years' experience in medical devices, MedTech, or pharma distribution.
- Strong working knowledge of ISO13485, MDR requirements, and distribution regulations (e.g., WDA).
- Experience with QMS processes, audits, CAPA, deviations, and supplier management.
- Excellent communication, influencing, and stakeholder engagement skills.
- Strong analytical, problem solving, and organisational abilities.
- Clean driver's licence and ability to travel; travel across sites in both domestic and European regions may be required.
Unipharmedtech
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