Description
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:
QualityJob Sub Function:
Customer/Commercial QualityJob Category:
ProfessionalAll Job Posting Locations:
Bogotá, Distrito Capital, Colombia, Juarez, Chihuahua, MexicoJob Description:
Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.
DePuy Synthes is recruiting for a CQ Analyst located in Mexico City Mexico or Bogota Colombia.
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 global 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).
Experience and Skills:
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.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
#LI-Hybrid
#DePuySynthesCareers
Required Skills:
Preferred Skills:
Audit Management, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment