9 дней назад
EMEA Staff Quality Specialist Service & Repair (Orthopedics)
64 000 - 103 040€
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
EMEA Staff Quality Specialist Service & Repair (Orthopedics) (Medical Devices/Quality): Strengthening quality and compliance across orthopedic medical-device service centers with an accent on quality-system execution, equipment validation, supplier qualification, and audit readiness. Focus on coordinating regional quality plans, resolving CAPAs and nonconformances, analyzing performance data, and leading harmonization and continuous-improvement initiatives.
Location: Amersfoort, Utrecht, Netherlands; travel of 5–10% may be required.
Base pay: €64,000–€103,040 per year, plus bonus and benefits.
Company
Johnson & Johnson MedTech develops healthcare and medical-device solutions, including orthopedic products and service operations.
What you will do
- Act as the quality and compliance contact for assigned EMEA service centers.
- Coordinate regional quality plans, oversee QMS execution, and identify systemic compliance gaps.
- Support equipment and computer-system validation, supplier qualification, and service-process harmonization.
- Track quality metrics and coordinate resolution of nonconformances, CAPAs, deviations, and audit observations.
- Support internal and external audits, update procedures, manage service-level agreements, and deliver training on procedural changes.
- Lead data-driven analysis and continuous-improvement initiatives across the Service & Repair network.
Requirements
- Bachelor’s degree in engineering, a scientific discipline, or quality and compliance; equivalent relevant industry experience may be accepted.
- At least 5 years of quality experience, preferably in medical devices and equipment validation.
- Experience in regulated ISO 13485 industries and quality management systems.
- Strong communication, analytical, organizational, conflict-resolution, and risk-based decision-making skills.
- Fluent English is required.
- Ability to work independently and collaboratively under time pressure and travel 5–10% when required.
Nice to have
- Lean Six Sigma Green or Black Belt, Project Management, or ASQ certification.
- Experience with EtQ, TrackWise, Windchill, or Salesforce service-and-repair systems.
- Additional language skills.
- Understanding of AI concepts, responsible AI practices, and effective prompt generation.
Culture & Benefits
- Inclusive work environment focused on individual contribution, diversity, and dignity.
- Annual performance-based bonus or sales commissions, depending on role and location.
- Vacation, parental leave of at least 12 weeks, bereavement, caregiver, and volunteer leave.
- Well-being reimbursement and financial, physical, and mental health programs.
- Recognition awards and access to applicable insurance plans.
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