Surgery Commercial Quality Senior Analyst

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

Job Description:

We're looking a Surgery Commercial Quality Sr. Analyst based in Bogotá, Colombia

Overall Purpose of Job

Ensure compliance with policies and procedures described in the Quality Management System applicable to the Companies mentioned in the MT LATAM Quality Manual, distribution channels and requirements indicated by Local Quality Regulations. Establishes and maintains quality assurance programs, procedures and controls, ensuring that performance parameters of both the products and quality system elements are continually measured to drive improvement initiatives. Ensure compliance for training and qualification program, records management and document control, change control process and samples management for human and non-human use. Ensure compliance with policies and procedures described in the MT LATAM Quality Manual applicable to the role and requirements indicated by Local Quality Regulations..

Responsibilities:

Quality Management System & Compliance

• Ensure compliance with company policies, procedures, and quality standards.
• Support the implementation of applicable requirements to the Quality System, including requirements from the MT Segment and global, regional, or local requirements.
• Support investigations of non-conformances and the definition of preventive and corrective actions through root cause analysis, and participate in meetings with the other areas involved.
• Document Non-Conformities in the DES (Designated Electronic System), ensuring compliance with the different stages: identification, investigation, cause analysis, correction, implementation of corrective and preventive actions, and verification of effectiveness.
• Support local and regional projects that have an impact on the Quality Management System.
• Ensure compliance with Good Practices and EHS Regulations, among other company policies and guidelines.

Technovigilance & Post-Market Surveillance

• Serve as Technovigilance Surveillance Responsible, managing and reporting to health authorities serious and non-serious adverse events related to medical devices, as provided in Resolution 4816 of 2008.
• Support the process related to technology-controlled reports, Quarterly Reports, and traceability according to the frequency established by the Health Authority.
• Support the Product Complaint process in Colombia and the Post-Market Surveillance Program, including POLO products.
• Support the collection of product complaint samples.
• Be responsible for the shipment of product complaint samples to the operating company.
• Support the process of implantable cards.

Product Quality & Lifecycle

• Be responsible for local product discontinuation and NPI (New Product Introduction) processes.
• Be responsible for the analysis and evaluation of Local Opportunity Products (POLO).
• Interact with manufacturing plants to manage local reconditioning in compliance with the company's Repack & Relabel requirements.
• Support Safety Datasheet requests and franchise submissions.
• Support Copy Review activities.

Change Control & Quality Documentation

• Support the Change Control execution process, ensuring that changes are evaluated, registered, reviewed, and approved prior to implementation.
• Support document control and records management processes, ensuring compliance with company procedures.
• Deploy recall, stop shipment, and sanitary alert processes as required by Quality Management.

Training & Samples Management

• Manage the training process, ensuring compliance with the defined metrics for timelines and completion and with the minimum requirements established in the Curriculum Matrix.
• Support the samples management process, including samples for human use and non-human use.
• Support the onboarding process.

SAP, Systems & Digital Quality Activities

• Perform material data transactions in SAP (Master Data).
• Support activities for the creation and maintenance of product master data in SAP.
• Support Local RIM activities.
• Support Computer System Validation Management activities.
• Support the creation of purchase orders related to processes within the Commercial Quality area.

Audits & Regulatory Inspections

• Support all relevant aspects during the receipt of local or external Regulatory Bodies inspections.
• Support relevant aspects during the receipt of Internal Audits.

Business Continuity / Backup

• According to the established backup system, if required, the Commercial Quality Supervisor or Specialist will support the activities described in this job description.

Qualifications

Education

• Bachelor’s degree in Pharmaceutical Chemistry, Biomedical Engineering, Chemical Engineering, or a related scientific, engineering, or healthcare field.

Experience & Knowledge

• Experience or knowledge in Quality Management Systems within a regulated environment.
• Knowledge or exposure to Technovigilance, Post-Market Surveillance, Product Complaints, CAPA, Non-Conformance Management, and/or Change Control.
• Experience within the Medical Devices industry is preferred.
• Candidates with relevant experience in Pharmaceuticals, Pharmacovigilance, Diagnostics, or other highly regulated healthcare environments may also be considered.
• Knowledge of SAP / Master Data, document control, records management, and regulatory requirements is preferred.
• Experience supporting regulatory inspections and/or internal audits is preferred.
• Experience working with quality processes related to New Product Introduction, product discontinuation, product complaints, or post-market activities is preferred.

Technical & Digital Skills

• Knowledge of Quality Management Systems and applicable quality procedures.
• Knowledge of CAPA, root cause analysis, and Non-Conformance Management.
• Familiarity with SAP and Master Data activities is preferred.
• Interest or experience in digital tools, process improvement, automation, AI, or digital solutions is preferred.
• Ability to identify opportunities to improve or automate operational processes.

Languages

• English proficiency is must, with the ability to participate in meetings and projects with regional or global stakeholders.

Key Competencies

• Ability to work independently and take ownership of assigned activities.
• Ability to manage projects and activities with increasing levels of autonomy.
• Strong initiative and willingness to learn.
• Ability to collaborate effectively with cross-functional teams.
• Strong analytical and problem-solving skills.
• Ability to work within a highly regulated environment and maintain compliance with established procedures.
• Growth mindset and ability to develop expertise in specialized Quality and Technovigilance processes.

Required Skills:

Preferred Skills:

AI Judgement Integration, Business Behavior, Compliance Management, Continuous Improvement, Data Analysis, Data Compilation, Detail-Oriented, Execution Focus, Goal Attainment, Internal Controls, Issue Escalation, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report Writing