7 дней назад
CQ Analyst - Mexico (MedTech)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
CQ Analyst - Mexico (MedTech): Supporting commercial quality activities for medical device operations in Mexico with an accent on regulatory compliance, post-market surveillance, audits, and quality documentation. Focus on monitoring quality trends, supporting corrective and preventive actions, and coordinating compliant distribution with Commercial, Regulatory Affairs, and Supply Chain teams.
Location: Mexico City, Mexico or Bogotá, Colombia; limited occasional domestic travel within Mexico.
Company
Johnson & Johnson MedTech develops healthcare and medical device solutions, with the Orthopaedics business planned to operate as DePuy Synthes following the announced separation.
What you will do
- Support commercial quality activities for sales, distribution, and post-market operations.
- Assist with complaint handling, adverse event reporting, post-market surveillance, and field action support.
- Collaborate with Commercial, Regulatory Affairs, and Supply Chain teams on compliant product distribution and lifecycle activities.
- Apply global and local quality procedures, work instructions, and internal controls.
- Participate in internal audits, external audits, and health authority inspections.
- Monitor quality issues, trends, and metrics while supporting corrective and preventive actions and continuous improvement.
Requirements
- Bachelor’s degree in Quality, Engineering, Life Sciences, Regulatory Affairs, or a related discipline.
- 2–4 years of experience in Quality, Regulatory, or Compliance roles within a regulated industry.
- Foundational knowledge of quality system requirements and regulatory expectations for commercial operations.
- Experience supporting post-market surveillance activities, audits, or inspections.
- Strong attention to detail, documentation, organization, communication, and cross-functional collaboration skills.
- Spanish required; English proficiency preferred.
Nice to have
- Experience in medical devices, healthcare, or another highly regulated industry.
- Familiarity with Mexican regulatory and quality requirements, including COFEPRIS.
- Experience in a multinational or matrixed organization.
- Quality or Regulatory certifications and exposure to health authority interactions.
Culture & Benefits
- Inclusive work environment focused on individual dignity, diversity, and equal opportunity.
- Work supporting patient safety, regulatory compliance, and business continuity.
- Limited travel, with occasional domestic travel within Mexico.
- Employment is expected to transition to DePuy Synthes after the planned business separation, subject to applicable approvals and consultation requirements.
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