Quality Manager, Latin America

embecta; Ciudad de México; Presencial; MXN 700,000 - 900,000; Jornada completa

Descripción de la vacante

A global medical device firm is seeking a Quality Manager in Latin America to standardize and deploy quality processes across the region. The role requires strong leadership in compliance, oversight of quality standards, and driving continuous improvement initiatives. The ideal candidate will hold a relevant degree and have extensive experience in quality management within the medical device sector, particularly ISO 13485 systems.

Servicios

Competitive pay

Continuous learning opportunities

Career growth support

Formación

• 5–7 years of experience in quality within the medical device sector; at least 2 years in a leadership role.
• Proven experience managing ISO 13485 quality systems in medical devices.
• Track record of driving continuous improvement using Lean or Six Sigma.

Responsabilidades

• Ensure compliance with ISO 13485 and regulatory standards.
• Drive initiatives to improve quality performance and reduce errors.
• Conduct routine quality oversight at Distribution Centers.

Conocimientos

Fluent in Spanish and English

Quality management expertise

Leadership abilities

Risk mitigation skills

Educación

Bachelor of Science in a related discipline

Master’s degree preferred

Herramientas

Microsoft tools

SAP

ETQ

Descripción del empleo

Overview

embecta is a global diabetes care company that leverages its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. For more information, visit embecta.com or follow our social channels on LinkedIn, Facebook, Instagram and X (http://twitter.com/embecta).

Why join us?

Our team values opinions and contributions and empowers you to bring your authentic self to work. Our employees can fulfill their life’s purpose through the work they do every day.

You will learn and work alongside inspirational leaders and colleagues who are passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program includes competitive pay, benefits, continuous learning, recognition, career growth and life balance components to support the needs of our diverse and global workforce.

Reporting to the Director, Distribution Quality Management, the Quality Manager of Latin America will focus on standardizing and deploying best-in-class quality processes and communications across the Latin America region. In addition to maintaining a compliant quality system, this person will lead engagement with key internal customers (Regulatory Affairs, Operations Quality, Design Quality, Post Market Surveillance) and key external customers. This leader will drive alignment on quality-related processes, targets and goals to ensure consistent quality standards, regulatory compliance, and continuous improvement across the region.

Responsibilities

• Ensure compliance with ISO 13485 and 21CFR 820 processes.
• Verify that the distribution center and Latin America regional offices adhere to global and regional quality standards, including GDP.
• Identify and mitigate quality risks in logistics and warehousing.
• Drive initiatives to improve quality performance and reduce errors or complaints.
• Conduct routine on-site quality oversight at regional Distribution Centers, with travel approximately once or twice per month (~10–20% travel).
• Serve as Management Representative for embecta Mexico.
• Ensure compliance with importer requirements for Mexico.
• Collaborate with Post Market Surveillance to ensure complaints compliance and PMS processes are effective in the region.
• Maintain regulatory requirements and internal quality standards, including documentation, regular reviews, and timely corrective actions.
• Drive successful outcomes in internal and external audits; prepare for audits, address findings, and implement corrective actions.
• Implement quality improvement initiatives to enhance compliance, efficacy, and safety of embecta’s products; streamline processes and reduce defects.
• Improve key quality metrics such as defect rates, audit findings, and issue-resolution cycle times.
• Ensure embecta associates are compliant with training; govern training plans, track progress, and ensure training is current.
• Promote awareness of regulatory and Quality Management System requirements throughout the organization.
• Establish and revise processes, procedures, and metrics to support the global quality system.
• Foster strong working relationships with quality, operations, regulatory and commercial teams to ensure smooth transitions from product development to commercial operations.
• Contribute to site objectives by participating in strategic planning and developing quality targets for continuous improvement.
• Monitor progress of Quality KPIs and communicate results to the organization and senior management.
• Develop organizational structure and talent to execute quality imperatives while supporting company needs.
• Facilitate inspections and external audits to ensure the global Quality Management System is properly represented.
• Encourage cooperation between teams to resolve issues and mentor subordinates; retain/build organizational talent.
• Mentor and develop the quality systems team through training, guidance and support.
• Other duties as assigned.

Experience & Education

• Bachelor of Science in a scientific, technological, engineering, mathematical or related discipline; Master’s degree preferred.
• 5–7 years of experience in quality within the medical device sector; at least 2 years in a leadership role with progressive responsibility.
• Proven experience managing ISO 13485 quality systems in medical device or similar regulated environment, including developing and implementing QMS in line with global regulatory expectations.
• Experience supporting internal and external audits, with ability to prepare, address findings, and implement corrective actions.
• Track record of driving continuous improvement (Lean, Six Sigma) to enhance product quality and efficiency.
• Experience working with cross-functional teams (R&D, manufacturing, regulatory affairs) to integrate quality systems into development and production.
• Training in ISO 13485 or demonstrated extended experience in ISO 13485 with compliance to MDR, IVDR, FDA QSR and other global regulations.

Knowledge, Skills and Abilities

Technical Knowledge and Abilities

• Fluent in Spanish and English.
• Extensive knowledge of ISO 13485 and regional medical device requirements.
• Experience with Notified Bodies, FDA and health authorities.
• Expertise in ISO 14971 and related standards; familiarity with IVDR, MDR, MDSAP.
• Proficiency with technology platforms (Microsoft tools, SAP, ETQ).
• Strong leadership for mentoring and developing quality teams; champions continuous improvement.
• Ability to manage multiple projects with strong planning and execution skills.
• Ability to identify and mitigate risks related to quality and regulatory compliance.
• Professional communication and presence with the ability to interact with varied stakeholders, including executives.

People Manager Core Competencies

• Develops talent with integrity and measurable outcomes; fosters inclusivity and collaboration; maintains ethical standards and adapts to industry trends; communicates regularly with the team and manages performance issues proactively.

Customer Focus

• Prioritizes customer perspective in decision-making; crafts service practices to meet customer needs and seeks ways to improve satisfaction.

Decision Making

• Gathers and analyzes information ethically, considers external data, and makes timely decisions with diverse perspectives.

Driving Innovation

• Supports ethical innovation, encourages new solutions, and fosters a culture of creativity and inclusivity.

Emotional Intelligence Essentials

• Establishes trust, interprets emotions accurately, and manages responses; builds relationships and maintains inclusive practices.

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embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital status, sexual orientation, gender identity or expression, genetics, disability, military status, or any other protected status.