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Job Overview
The Commercial Quality Analyst – Mexico supports the execution of quality activities for commercial operations within the Mexican market.
This role helps ensure that sales, distribution, and post‐market activities comply with applicable regulatory requirements, quality system standards, and internal procedures.
The position contributes directly to patient safety, regulatory compliance, and business continuity while partnering with Commercial, Regulatory Affairs, and Supply Chain teams.
Key Responsibilities
Support commercial quality activities to ensure compliance with regulatory requirements, quality system standards, and internal policies.
Assist with post‐market surveillance activities, including complaint handling, adverse event reporting, and field action support.
Collaborate with Commercial, Regulatory Affairs, and Supply Chain teams to support compliant product distribution and lifecycle activities.
Support implementation and adherence to general and local quality procedures, work instructions, and controls.
Participate in internal audits, external audits, and health authority inspections as required.
Monitor quality issues, trends, and metrics within the local market and support corrective and preventive actions.
Maintain accurate quality documentation, records, and reports related to commercial quality activities.
Contribute to continuous improvement initiatives to strengthen quality compliance and operational effectiveness.
Qualifications
Education:
Bachelor's degree in Quality, Engineering, Life Sciences, Regulatory Affairs, or a related discipline (required).
Advanced degree in a scientific, quality, or regulatory field (preferred).




Required:
Typically 2‐4 years of experience in Quality, Regulatory, or Compliance roles within a regulated industry.
Foundational understanding of quality system requirements and regulatory expectations for commercial operations.
Experience supporting post‐market surveillance activities, audits, or inspections.
Ability to interpret quality procedures and regulatory requirements and apply them to daily activities.
Strong attention to detail, documentation, and organizational skills.
Effective communication and cross‐functional collaboration skills.
Preferred:
Experience in medical devices, healthcare, or other highly regulated industries.
Familiarity with Mexican regulatory and quality requirements (e.g., COFEPRIS).
Experience working in a multinational or matrixed organization.
Exposure to health authority interactions or regulatory inspections.
Quality or Regulatory certifications.
Other:
Language: Spanish required; English proficiency preferred.
Travel: Limited; occasional domestic travel within Mexico.
Certifications: Quality or Regulatory certifications preferred but not required.
Johnson & Johnson is an Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law.
We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
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📌 Mexico Commercial Quality Analyst (Bogotá)
🏢 Johnson & Johnson MedTech
📍 Bogotá