5 дней назад
CQ Sr Analyst (MedTech)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
CQ Sr Analyst (MedTech) (Quality Management Systems): Governing, deploying, and continuously improving commercial quality management systems across a regional medical device network with an accent on regulatory compliance, distribution controls, and patient safety. Focus on analyzing quality metrics, leading CAPA and change management activities, supporting audits and inspections, and harmonizing quality processes across countries.
Location: Bogotá, Colombia; hybrid work arrangement
Company
Johnson & Johnson MedTech develops healthcare and medical device solutions, with DePuy Synthes focused on orthopaedics.
What you will do
- Lead the implementation, maintenance, and continuous improvement of commercial Quality Management System requirements across the region.
- Provide quality oversight for product handling, storage, distribution, and other commercial operations.
- Manage quality processes including document management, training, investigations, CAPA, change management, risk management, and management reviews.
- Monitor quality metrics and trends, identify risks, and support data-driven continuous improvement.
- Partner with Commercial, Supply Chain, Distribution, Regulatory Affairs, Operations, and Global Quality stakeholders.
- Support audits, regulatory inspections, remediation activities, and regional quality initiatives.
Requirements
- Bachelor’s degree in Engineering, Life Sciences, Pharmacy, Quality, Regulatory Affairs, Supply Chain, Business Administration, or a related field.
- At least 5 years of experience in quality assurance, quality systems, supply chain quality, regulatory affairs, or a related function within a regulated industry.
- Experience implementing, maintaining, and improving Quality Management Systems and supporting commercial handling, storage, and distribution activities.
- Strong analytical, problem-solving, risk-based decision-making, communication, stakeholder management, and influencing skills.
- Fluent Spanish and Portuguese required.
- Limited domestic or international travel may be required, generally less than 10%.
Nice to have
- Experience in medical devices, healthcare, pharmaceuticals, or another regulated industry.
- Experience leading regional quality process deployments and supporting audits, inspections, or compliance programs.
- Advanced degree, quality certifications, auditor qualifications, or Six Sigma training.
- English proficiency.
Culture & Benefits
- Inclusive work environment focused on diversity, dignity, and equal opportunity.
- Work centered on quality, compliance, integrity, patient safety, customer focus, and accountability.
- Employment is expected to transition to DePuy Synthes following the planned separation of the Orthopaedics business, subject to legal and regulatory requirements.
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