7 дней назад
Quality Engineer (MedTech)
44 700 - 70 840€
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Quality Engineer (MedTech): Ensuring GMP-compliant quality management systems and supporting Operations objectives through nonconformance investigations, CAPA records, and end-to-end change controls with an accent on quality documentation, regulatory compliance, and sustainable issue resolution. Focus on root cause analysis, risk mitigation, audit support, data analysis, and driving continuous improvement in a regulated healthcare environment.
Location: Leiden, South Holland, Netherlands
Base pay: €44,700–€70,840 per year
Company
Johnson & Johnson develops healthcare solutions across Innovative Medicine and MedTech, including treatments and medical technologies designed to improve patient outcomes.
What you will do
- Apply quality expertise to support Operations objectives and ensure compliance with GMP and quality management requirements.
- Lead nonconformance investigations, CAPA records, and Change Controls from initiation through completion.
- Review and maintain quality documentation, procedures, and records for regulatory and internal compliance.
- Drive continuous improvement through risk mitigation initiatives, GEMBA walks, data analysis, and quality improvement projects.
- Support audits and inspections, develop GMP training initiatives, and collaborate with stakeholders on quality activities.
Requirements
- HBO degree with at least 3 years of relevant experience in Quality, Manufacturing, or a GMP-regulated industry.
- Experience leading or supporting quality investigations and change controls.
- Strong knowledge of GMP, CAPA, Change Control, quality systems, root cause analysis, risk management, and data analysis.
- Proficiency in MS Office and business applications.
- Strong communication, stakeholder management, analytical, prioritization, and problem-solving skills.
- Fluent English at B2 level required.
Nice to have
- Knowledge of GAMP, Lean Supply Chain Management, process control, quality control testing, and quality systems documentation.
- Experience with supply planning, supervision, issue escalation, or process improvement initiatives.
Culture & Benefits
- Inclusive work environment focused on individual respect, diversity, and dignity.
- Annual performance-based bonus or sales commissions, depending on pay grade and location.
- Vacation days, parental leave of at least 12 weeks, bereavement leave, caregiver leave, and volunteer leave.
- Well-being reimbursement and financial, physical, and mental health programs.
- Insurance plans and service anniversary and recognition awards, subject to applicable plan terms.
Hiring process
- Application and CV review followed by a short recruitment call for selected candidates.
- Successful candidates complete country-specific checks before starting.
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