6 дней назад
PQV Combination Product Analyst IV (MedTech)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
PQV Combination Product Analyst IV (MedTech): Managing high-volume end-to-end product quality complaints, adverse events, and Medical Device Reporting assessments with an accent on regulatory compliance, risk prioritization, and data-driven quality processes. Focus on leading investigations, driving corrective actions and process improvements, and coordinating change management across global quality, medical safety, manufacturing, and regulatory stakeholders.
Location: Schaffhausen, Switzerland; EMEA. Full-time role with up to 5–10% domestic and international travel.
Company
Johnson & Johnson MedTech develops healthcare and medical technology solutions across innovative medicine and MedTech.
What you will do
- Manage high-volume end-to-end product quality complaints, including intake, triage, investigation, risk assessment, closure, and trend analysis.
- Perform Medical Device Reporting assessments and document reportable and non-reportable regulatory decisions.
- Coordinate complaint governance, monitoring, prioritization, KPI performance, and escalation of quality issues.
- Lead root cause analysis, corrective actions, remediation activities, process mapping, and change management for complaint and MDR processes.
- Collaborate with medical safety, quality, manufacturing, clinical, regulatory, IT, and local operating company stakeholders.
- Support audits and inspections, provide subject-matter expertise, train system users, and lead special projects.
Requirements
- 5+ years of experience in quality assurance or quality control within pharmaceuticals, medical devices, or another highly regulated industry.
- Bachelor’s degree in a technical, scientific, or engineering discipline; a master’s degree is preferred.
- Knowledge of medical safety, complaint handling, MDR processes, risk assessment, root cause analysis, process mapping, and quality management systems.
- Experience with applicable regulations and standards, including 21 CFR, ICH Q10, GDP, GMP, GVP, ISO 13485, ISO 14971, CMDR, and the Medical Device Directive.
- Ability to lead projects and change initiatives, manage priorities independently, communicate with senior stakeholders, and influence cross-functional partners.
- Ability to work in Schaffhausen, Switzerland, within the EMEA role location, and travel domestically and internationally up to 5–10%.
Culture & Benefits
- Inclusive work environment guided by the company’s Credo and focused on respect, diversity, and individual contribution.
- Cross-functional collaboration with global quality, medical safety, manufacturing, regulatory, clinical, and technology organizations.
- Opportunities to lead process improvements, regulatory change initiatives, audits, inspections, and new product introduction activities.
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