Commercial Quality Senior Analyst

Johnson and Johnson; Buenos Aires; Presencial; ARS 900.000 - 1.400.000; Jornada completa

Descripción de la vacante

Johnson & Johnson MedTech in Buenos Aires seeks a Commercial Quality Senior Analyst to support governance and execution of quality processes for Argentina and Ecuador. You will work with cross-functional teams to ensure products, processes, and distribution channels meet high standards of quality, compliance, and patient safety.

This role focuses on compliance, regulatory readiness, and business continuity in a dynamic and highly regulated Latin America environment, partnering with Legal,

Formación

• Minimum of four years of experience in Quality Assurance.
• Advanced English proficiency required.
• Strong knowledge of Medical Device regulations applicable to Argentina.
• Knowledge of regulatory processes for Argentina's ANMAT will be a plus.

Responsabilidades

• Support governance and execution of Commercial Quality processes for Argentina and Ecuador MedTech.
• Assist audits, inspections, and regulatory authority interactions.
• Identify, assess, and drive closure of quality and compliance gaps with practical CAPA actions.
• Ensure products meet regulatory requirements across commercial and distribution channels.
• Lead or support non-conformance investigations and root cause analysis.
• Collaborate with cross-functional partners to embed quality into processes.

Conocimientos

Advanced English

MS Office

Quality Assurance

Argentina Regulations

Supplier Management

Educación

Bachelor's degree

Herramientas

QMS

Descripción del empleo

At Johnson & Johnson,we believe health is everything.
Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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: Buenos Aires, Argentina

About the Role

At Johnson & Johnson MedTech, we are working to transform the future of healthcare by bringing innovative medical technologies to patients and healthcare professionals around the world.
Joining our Commercial Quality team means helping ensure that our products, processes, and distribution channels meet the highest standards of quality, compliance, and patient safety. This position is responsible for supporting Commercial Quality processes governance and execution for Argentina and Ecuador MedTech, ensuring quality standards across commercial processes and distribution channels, with focus on compliance, operational excellence, and strategic business outcomes. As Commercial Quality Senior Analyst for Argentina and Ecuador MedTech, you will play a key role in supporting the governance and execution of Commercial Quality processes across the Local Operating Company.
You will partner with cross-functional teams to strengthen compliance, sustain audit readiness, and enable business continuity and growth in a dynamic, highly regulated environment.
The role ensures adherence to applicable J&J policies and procedures described in the Quality Management System for the Marketing Company and distribution channels, as well as global, regional, and local quality and regulatory requirements. This is an opportunity for a quality professional who enjoys working close to the business, connecting quality requirements with practical execution, and contributing to meaningful outcomes for patients, customers, and stakeholders across Latin America.

Key Responsibilities

• Partner with local and regional stakeholders to support the governance and execution of Commercial Quality processes for Argentina and Ecuador MedTech, ensuring alignment with J&J quality standards, procedures, and applicable regulatory requirements.
• Help sustain an audit-ready culture by supporting internal and external audits, inspections, and regulatory authority interactions, including preparation, coordination, follow-up, and timely closure of action plans.
• Identify, assess, and drive closure of quality and compliance gaps, escalating risks and potential risks appropriately while enabling practical and sustainable solutions.
• Support the assurance that products commercialized and distributed in Argentina and Ecuador meet applicable quality, regulatory, and J&J policy requirements across commercial and distribution channels.
• Lead or support non-conformance and CAPA investigations, including root cause analysis, definition of corrective and preventive actions, and collaboration with cross-functional partners to ensure effective implementation.
• Support supplier quality management activities, including qualification, monitoring, audits, audit action plan follow-up, routine quality support, and risk management for suppliers and service providers.
• Collaborate with Procurement, Legal, Marketing, Regulatory Affairs, Supply Chain, Commercial teams, distributors, and other business partners to embed quality requirements into operational and business processes.
• Draft, review, and support the implementation of new or updated procedures, while identifying performance trends, process opportunities, and continuous improvement initiatives.
• Lead or support gap assessments and implementation plans for new regulatory or quality requirements in partnership with Regulatory Affairs and applicable business stakeholders.
• Act as a trusted Commercial Quality partner to business stakeholders, providing guidance, connecting requirements with execution, and supporting compliant business continuity.
• Represent J&J MedTech in trade associations and appropriate external forums related to the Medical Device sector, as needed.
• Contribute to the broader Brazil and Latin America Commercial Quality community by sharing best practices, collaborating across markets, and working as part of One Team.

Mandatory Qualifications

• Advanced English is required.
• Intermediate or advanced proficiency in Microsoft Office tools, including Word, Excel, PowerPoint, and internet-based applications.
• Solid knowledge of Medical Device regulations applicable to Argentina is required.
• Knowledge of Medical Device regulations applicable to Ecuador is a plus.
• Minimum of four years of experience in Quality Assurance.

Preferred Qualifications

• Bachelor's degree in any field; Health Sciences or Engineering are preferred.
• Previous experience in supplier management is preferred.
• Previous experience in Regulatory Affairs and regulatory processes for Argentina's ANMAT and Ecuador's ARCSA will be considered a plus.
• Project management skills will be considered a plus.

Key Competencies Required for this Role

• Strong communication skills and ability to influence cross-functional stakeholders.
• Strong analytical and problem-solving capabilities.
• Interpersonal skills and collaborative mindset.
• Organizational skills and ability to manage priorities in a dynamic environment.
• Proactivity, accountability, and continuous improvement mindset.

Company

• Argentina - Buenos Aires
• J&J MedTech Required Skills: Preferred Skills: Business Alignment, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Human-Centered Design, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards