8 дней назад
Document Control Specialist (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
Document Control Specialist (Medtech): Controlling product documentation, engineering changes, BOMs, and product data across Arena PLM and Oracle ERP with an accent on regulatory compliance, traceability, and production readiness. Focus on reviewing R&D phase-gate deliverables, coordinating ECOs and DCOs, and maintaining audit-ready documentation under ISO 9001 and ISO 13485 requirements.
Location: Brno, Czech Republic; hybrid work with up to 2 days per week from home. Legal eligibility to work in the Czech Republic is required. Occasional travel may be required, less than 10%.
Company
develops precision components and subsystems for healthcare, advanced manufacturing, minimally invasive surgery, robotics, and 3D metal printing.
What you will do
- Prepare, review, circulate, and implement ECOs, DCOs, QCOs, manufacturing changes, and deviations in Arena PLM.
- Release firmware, drawings, components, documents, BOMs, and other product artifacts throughout the product lifecycle.
- Maintain accurate BOM structures and ensure correct transfer of product data between Arena PLM and Oracle ERP.
- Support Manufacturing Engineering with work instructions, loader application setup, pilot builds, and production readiness activities.
- Review R&D project phase-gate deliverables for completeness, accuracy, and audit readiness.
- Maintain controlled documentation in line with applicable quality system and regulatory requirements.
Requirements
- Bachelor’s degree in engineering, business, economics, life sciences, or a related field, or equivalent practical experience.
- Experience in document control, PLM, engineering support, quality, technical writing, or a related role.
- Knowledge of engineering design processes, document control systems, and engineering change processes.
- Experience with a PLM, CMS, or ERP system; Arena is preferred but not required.
- Very good spoken and written English and communicative Czech are required.
- Legal eligibility to work in the Czech Republic is required. Familiarity with ISO 9001 and ISO 13485 is preferred.
Culture & Benefits
- 25 days of vacation, 5 sick days, and one paid charitable-activity day annually.
- Flexible working hours with core hours from 10:00 to 15:00.
- Flexi Pass vouchers, supplementary pension contributions, meal vouchers, and a home-working allowance.
- Training, language courses, career development, and employee referral bonuses.
- Family-friendly, dog-friendly workplace with refreshments, parking, and employee events.
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