Manager, CQ Lead Mexico & Northern Cluster

Job 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: Quality Job Sub Function: Customer/Commercial Quality Job Category: People Leader All Job Posting Locations: Bogotá, Distrito Capital, Colombia Job Description: DePuy Synthes is recruiting for position, located in Bogota, Colombia or Mexico City Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): Bogota , Colombia - Requisition Number: R-093359 Mexico City - Requisition Number: R-094882 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. 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. At DePuy Synthes, Quality Affairs professionals play a critical role in ensuring that products, processes, and services meet applicable regulatory requirements and quality standards while supporting patient safety and business performance. This position provides an exciting opportunity to work cross-functionally with manufacturing, supply chain, regulatory, and quality teams to maintain compliant systems, drive continuous improvement, and support operational excellence. The successful candidate will help ensure quality system effectiveness while contributing to key initiatives that enable safe, innovative orthopedic solutions for patients worldwide. Key Responsibilities Support the execution and maintenance of Quality Management System (QMS) processes and related documentation. Coordinate quality and compliance activities to ensure alignment with internal procedures and applicable regulatory requirements. Assist with internal and external audits, inspections, and compliance assessments. Review, maintain, and control quality documentation, records, procedures, and training materials. Support investigations, corrective and preventive actions (CAPA), and continuous improvement initiatives. Analyze quality metrics, trends, and performance indicators and prepare reports for stakeholders. Collaborate with cross-functional teams to ensure quality standards are understood, implemented, and maintained across operations Maintain accurate records and support readiness for regulatory submissions, inspections, and audits. Research changes in regulatory requirements and industry standards and support implementation activities. Promote a culture of compliance, continuous improvement, and patient-focused quality. Qualifications Education: Bachelor’s degree required in Life Sciences, Engineering, Quality, Regulatory Affairs, Biomedical Sciences, or a related discipline. Advanced degree or relevant postgraduate qualification preferred. Experience and Skills: Required: Experience working in a regulated quality, compliance, regulatory affairs, or medical device environment. Knowledge of quality systems, documentation controls, and compliance processes. Ability to review quality records, audit findings, and inspection outcomes and support corrective actions. Strong analytical, organizational, and problem-solving skills. Experience using Microsoft Office applications and quality-related systems. Generally requires 2–4 years of relevant work experience. Preferred: Experience in the medical device, orthopedics, healthcare, or life sciences industry. Working knowledge of ISO quality standards, quality management systems, and applicable regulatory frameworks. Experience supporting audits, inspections, CAPA activities, and quality improvement initiatives. Familiarity with document control, change management, and training compliance processes. Experience analyzing quality data and developing recommendations for process improvements. Effective written and verbal communication skills with the ability to work across functions. Professional certification in Quality or Regulatory Affairs (e.g., ASQ, RAC) preferred. Experience working within a global, matrixed organization. Other: Language: English proficiency required. Travel: Up to 10% domestic and international travel, as business needs require. Certifications: ASQ, RAC, Lean Six Sigma, or similar quality certifications preferred. Valid work authorization for the United Kingdom required. Valid driver’s license may be required depending on business needs. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com. 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: Compliance Management, Continuous Improvement, Corrective and Preventive Action (CAPA), Developing Others, Fact-Based Decision Making, Give Feedback, Inclusive Leadership, ISO 9001, Leadership, Performance Measurement, Quality Control (QC), Quality Management Systems (QMS), Quality Processes, Quality Standards, Standard Operating Procedure (SOP), Team Management