CQ Specialist

Johnson Johnson; Bogotá ciudad; Presencial; COP 293.026.000 - 423.260.000; Jornada completa

Descripción de la vacante

Johnson & Johnson’s DePuy Synthes division is recruiting a Commercial Quality Specialist for LATAM, based in Bogota, Colombia or Sao Paulo, Brazil. The role leads QMS deployment, compliance, and continuous improvement across the region, collaborating with Commercial, Distribution, Supply Chain, Regulatory Affairs, and Global Quality.

You will serve as SME for quality system processes, oversee handling, storage and distribution activities, manage audits, CAPA, change control, and risk management,

Formación

• Minimum 5 years in Quality Assurance, Quality Systems, or related roles in regulated industries.
• Experience implementing and improving Quality Management Systems.
• Experience supporting commercial operations within healthcare or medical devices.
• Spanish and Portuguese fluency; English desirable.

Responsabilidades

• Lead the implementation and sustainment of QMS requirements, procedures, systems, and initiatives across the region, ensuring alignment with business needs and regulatory requirements.
• Provide quality oversight for handling, storage, distribution, and other commercial operations, ensuring controls are in place to protect product quality and patient safety.
• Drive compliance and effectiveness of quality system processes including document management, training, investigations, CAPA, change management, quality risk management, and management review activities.
• Monitor and analyze quality metrics, trends, and process performance indicators to identify risks, drive continuous improvement, and support management decisions.

Conocimientos

Quality Assurance

Regulatory Affairs

Cross-functional collaboration

Spanish

Portuguese

Educación

Bachelor's Degree

Advanced degree

Descripción del empleo

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function

Quality

Job Sub Function

Customer/Commercial Quality

Job Category

Professional

All Job Posting Locations

Bogotá, Distrito Capital, Colombia, São Paulo, Brazil

Job Description

DePuy Synthes is recruiting for a CQ Specialist located in Bogota, Colombia and Sao Paulo, Brazil.

Job Overview

The Commercial Quality Specialist, LATAM is responsible for the governance, deployment, maintenance, and continuous improvement of the Commercial Quality QMS across the region. This role serves as a Subject Matter Expert (SME) for quality system processes and ensures compliance with applicable regulatory requirements, company standards, and commercial quality policies.

The position partners closely with Commercial, Distribution, Supply Chain, Regulatory Affairs, Operations, and Global Quality organizations to ensure effective implementation and sustainability of quality system processes throughout the commercial network. The role also supports the deployment of regional quality initiatives, drives process harmonization across countries, and promotes a culture of quality and compliance.

Key Responsibilities

• Lead the implementation and sustainment of QMS requirements, procedures, systems, and initiatives throughout the region, ensuring alignment with business needs and applicable regulatory requirements.
• Provide quality oversight for handling, storage, distribution, and other commercial operations, ensuring appropriate controls are established and maintained to protect product quality and patient safety.
• Drive compliance and effectiveness of quality system processes including document management, training, investigations, CAPA, change management, quality risk management, and management review activities.
• Monitor and analyze quality metrics, trends, and process performance indicators to identify risks, drive continuous improvement initiatives, and support management decision-making.
• Partner with Commercial, Supply Chain, Distribution, Regulatory Affairs, and Global Quality stakeholders to ensure consistent execution of quality requirements and resolution of quality and compliance issues.
• Provide technical guidance, training, and quality expertise to regional teams, supporting the development of quality capabilities and a culture of compliance and continuous improvement.
• Support internal and external audits, regulatory inspections, and assessment activities, ensuring audit readiness and effective remediation of identified gaps.
• Demonstrate DePuy Synthes's Credo values in all activities through a commitment to quality, compliance, integrity, patient safety, customer focus, and accountability.

Qualifications

Education

• Bachelor's Degree required in Engineering, Life Sciences, Pharmacy, Quality, Regulatory Affairs, Supply Chain, Business Administration, or a related field.
• Advanced degree is preferred.

Experience and Skills

Required

• Minimum 5 years of experience in Quality Assurance, Quality Systems, Supply Chain Quality, Regulatory Affairs, or other quality-related functions within a regulated industry.
• Experience implementing, maintaining , and improving Quality Management Systems.
• Experience supporting commercial operations, including handling, storage, and distribution activities.
• Experience working in cross-functional and regional environments.
• Strong analytical, problem-solving, and risk-based decision-making skills.
• Strong communication , stakeholder management, and influencing skills.
• Fluent in Spanish and Portuguese.

Preferred

• Experience within the Medical Device, Healthcare, Pharmaceutical, or related regulated industry.
• Experience leading regional deployment of quality processes, systems, or initiatives.
• Experience supporting audits, inspections, and compliance programs.
• English proficiency is desirable.

Other

• Travel: Limited domestic or international travel may be required ( generally 10%).
• Quality-related certifications, auditor qualifications, or equivalent professional training are preferred. (e.g., ISO Internal/Lead Auditor, ASQ Certified Quality Engineer, Six Sigma certifications).

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