5 дней назад
Commercial Quality Specialist, Supplier Management (MedTech)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Commercial Quality Specialist, Supplier Management (MedTech): Managing regional quality system processes and supplier quality activities for regulated medical device products with an accent on QMS governance, supplier investigations, CAPA, audits, and EMEA regulatory compliance. Focus on coaching stakeholders, standardizing quality processes, reporting KPIs, supporting inspection readiness, and driving continuous improvement across the region.
Location: Hybrid role available in Issy-les-Moulineaux or Paris, France; Dublin, Ireland; or Zuchwil, Switzerland. Limited travel may be required.
Company
Johnson & Johnson MedTech develops healthcare and medical device solutions, with the role expected to transition to DePuy Synthes following the planned separation of the Orthopaedics business.
What you will do
- Manage assigned quality system processes and act as a regional subject matter expert across EMEA.
- Provide guidance, coaching, and support on quality processes and systems, including document control, quality agreements, change control, purchasing controls, audits, CAPA, and training.
- Drive simplification, standardization, and continuous improvement of regional quality processes.
- Communicate compliance requirements and status to affected sites and organizations.
- Report process metrics and KPIs consistently and on time.
- Support regional audit and inspection readiness and collaborate with internal and external stakeholders on quality solutions.
Requirements
- Bachelor’s degree in engineering, life sciences, supply chain, or a related scientific or technical discipline; an advanced degree is preferred.
- 4–6 years of experience in quality assurance, commercial quality, or supplier quality management within a regulated medical device or pharmaceutical environment.
- Experience leading supplier-focused quality activities and managing supplier investigations, nonconformances, and CAPA.
- Strong knowledge of quality management systems, supplier quality processes, ISO certification, and EMEA medical device regulations.
- Experience with notified bodies or health authority inspections is preferred.
- Fluent English is required. Strong analytical, organizational, problem-solving, cross-functional collaboration, and stakeholder-influencing skills are expected.
Nice to have
- Experience with EU MDR-regulated medical devices.
- Experience conducting or supporting supplier audits and assessments.
- Experience with orthopaedic or implantable medical devices.
- Knowledge of supplier performance metrics, risk-based monitoring, continuous improvement, or risk management methodologies.
- Quality-related certifications such as ISO or ASQ.
Culture & Benefits
- Inclusive work environment focused on individual dignity, diversity, and equal opportunity.
- Annual bonus or sales commissions depending on pay grade, location, and performance.
- Vacation, parental, bereavement, caregiver, and volunteer leave.
- Well-being reimbursement and financial, physical, and mental health programs.
- Recognition awards and access to insurance plans subject to local eligibility and plan terms.
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