6 дней назад
QMS Staff Engineer (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
QMS Staff Engineer (MedTech): Establishing, maintaining, and continuously improving a medical-device Quality Management System in Beijing with an accent on China Medical Device GMP, ISO 13485, compliance management, and audit readiness. Focus on managing CAPA and quality metrics, controlling regulatory and artwork documentation, developing training systems, and supporting eQMS deployment.
Location: Beijing, China
Company
Johnson & Johnson MedTech develops healthcare and medical-device solutions as part of Johnson & Johnson.
What you will do
- Establish, implement, maintain, and continuously improve the Quality Management System in line with China Medical Device GMP, ISO 13485, company requirements, and applicable regulations.
- Monitor QMS performance through quality objectives, NCs, CAPAs, KPIs, and management reviews, ensuring processes remain effective and audit-ready.
- Manage compliance monitoring, regulatory change implementation, gap assessments, audit preparation, inspection findings, and remediation closure.
- Own document and data control, including quality records, regulatory documentation, artwork files, approvals, revisions, retention, and archival.
- Develop the quality and compliance training system, annual training plans, training matrices, competency assessments, and inspection-ready training records.
- Lead annual report preparation and submission, communicate with regulatory authorities, and support deployment and management of the electronic QMS.
Requirements
- Experience managing Quality Management Systems and quality processes in a regulated environment.
- Knowledge of China Medical Device GMP and ISO 13485, applicable medical-device regulations, and quality standards.
- Experience with compliance management, internal and external audits, regulatory inspections, CAPA, quality metrics, and continuous improvement.
- Experience with SOPs, quality records, document and data control, training systems, and competency management.
- Ability to coordinate with regulatory authorities, external partners, global process owners, and internal stakeholders.
- Ability to support employee compliance with applicable company, local, and regulatory requirements.
Nice to have
- Experience supporting electronic Quality Management System deployment.
- Leadership, team management, developing others, inclusive leadership, and fact-based decision-making skills.
Culture & Benefits
- Full-time position within a healthcare and medical-device organization.
- Work focused on regulatory compliance, patient-oriented healthcare innovation, and quality-system effectiveness.
- Inclusive work environment that recognizes individual contributions and diversity.
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