4 часа назад
Director, Quality Operations (Medical Device)
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
Director, Quality Operations (Medical Device): Leading quality engineering, assurance, control, incoming quality, and quality systems for a large-scale medical device manufacturing site with an accent on regulatory compliance, manufacturing quality, and site expansion readiness. Focus on leading FDA and ISO audits, managing CAPA and validation programs, strengthening risk-based decision making, and building quality capabilities during the transition from a greenfield launch to onsite operations.
Location: Heredia, Costa Rica. The role starts remotely due to the launch of a new greenfield site and transitions to onsite work once the facility is ready.
Company
develops the Omnipod wearable medical device platform to help customers live simpler, healthier lives.
What you will do
- Lead Quality Engineering, Quality Assurance, Quality Control, Incoming Quality, and Quality Systems across the Costa Rica manufacturing site.
- Develop and execute the site Quality strategy in alignment with global Quality and business objectives.
- Represent Quality during FDA inspections, MDSAP audits, ISO 13485 certification audits, customer audits, and corporate assessments.
- Oversee CAPA, nonconformance management, management review, audits, complaints, validation, environmental monitoring, training, and product release processes.
- Lead quality readiness for site expansion, capacity growth, inspections, certifications, and commercialization programs.
- Manage quality budgets, performance metrics, risk management, and data-driven improvement initiatives.
Requirements
- Bachelor's degree in Engineering, Science, or a related discipline; an advanced degree is preferred.
- 12+ years of progressive medical device quality leadership experience, including significant manufacturing quality responsibility.
- 10+ years leading managers and professional quality organizations in regulated environments.
- Strong knowledge of FDA Quality System Regulations, ISO 13485, MDR, risk management, validation, and quality engineering principles.
- Experience leading through inspections, customer and regulatory audits, and organizational change.
- Experience with site start-ups, transfers, rapid-growth operations, or large-scale manufacturing expansions is preferred.
Nice to have
- Advanced degree in a relevant discipline.
- Experience supporting greenfield site launches and large-scale manufacturing expansion.
Culture & Benefits
- Initial remote work arrangement during the greenfield site launch.
- Transition to onsite work after the facility is ready.
- Opportunity to shape quality culture, capabilities, and systems at a new manufacturing site.
- Collaboration with Global Quality, Operations, Supply Chain, Regulatory, and Engineering teams in a global matrix organization.
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