Quality Manager, Latin America

Buscojobs México; Estado de México; Presencial; MXN 1,496,000 - 1,871,000; Jornada completa

Descripción de la vacante

A global medical solutions provider is seeking a Quality Manager for Latin America to standardize quality processes and drive continuous improvement. This role requires extensive knowledge of ISO 13485 and leadership in the medical device sector. Candidates must be fluent in both Spanish and English and have a proven track record in quality management and compliance. This position significantly contributes to maintaining regulatory standards across the region.

Servicios

Competitive pay

Benefits package

Career growth opportunities

Formación

• 5-7 years of experience in quality within the medical device sector.
• At least 2 years in a leadership role with demonstrated progressive responsibility.
• Proven experience in managing ISO 13485 quality systems.

Responsabilidades

• Ensure compliance with ISO 13485 and 21CFR 820 process.
• Lead the engagement with key internal and external customers.
• Drive initiatives to improve quality performance.

Conocimientos

Leadership skills

Fluent in Spanish

Fluent in English

ISO 13485 knowledge

Continuous improvement techniques

Educación

Bachelor of Science in a relevant discipline

Master of Science preferred

Herramientas

Microsoft applications

SAP

Descripción del empleo

embecta is a global diabetes care company that is leveraging 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.

Why join us?

A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our employees can fulfill their life’s purpose through the work that they do every day.

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

Position overview

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 the engagement and interaction with key internal customers specifically Regulatory Affairs, Operations Quality, Design Quality, and Post Market Surveillance teams along with key external customers. This leader will drive alignment on quality related processes, targets, and goals. This role is crucial for ensuring consistent quality standards across the Latin America region, maintaining regulatory compliance, and fostering continuous improvement to support embecta's mission of empowering people through innovative medical solutions.

RESPONSIBILITIES

• Ensuring compliance with ISO 13485 and 21CFR 820 process
• Verify that the distribution center and Latin America regional offices adhere to global and regional quality standards, including Good Distribution Practices (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 the regional Distribution Centers, with travel approximately once or twice per month (10–20% travel time), to ensure compliance with quality systems, support continuous improvement initiatives, and maintain inspection readiness.
• Management Representative for embecta Mexico
• Compliance with importer requirements for Mexico
• Work with Post Market surveillance to ensure complaints compliance and PMS processes are effective and fit for purpose in the Latin America region.
• Ensure compliance with regulatory requirements and internal quality standards, maintaining up-to-date documentation and records, conducting regular reviews, and implementing corrective actions promptly.
• Drive successful outcomes in all internal and external audits, including preparing for audits, addressing findings swiftly, and continuously improving processes to prevent recurrence of issues.
• Implement quality improvement initiatives focused on enhancing quality compliance, efficacy and safety of embecta’s products by streamlining processes and reducing process defects or non-conformities.
• Foster improvement in key quality metrics, such as defect rates, audit findings, and cycle times for issue resolution.
• Ensure embecta associates are compliant with training, governance of training plans, tracking progress, and ensuring training is relevant and up to date.
• Positive feedback from internal and external stakeholders highlighting the effectiveness and consistency of quality systems.
• Promotes awareness of applicable regulatory requirements and Quality Management System requirements throughout the organization.
• Establish and/or revise processes, procedures, and metrics to support the global quality system and processes.
• Establish excellent working relationships with quality, operations, regulatory, and commercial teams to ensure successful transitions from product development projects into commercial operations.
• Contribute to the achievement of site objectives by participating in strategic planning, including development of quality targets for continuous quality improvement.
• Monitor progress of Quality KPIs and communicate to the organization and senior management.
• Develop the organizational structure and talent to execute the Quality imperatives while supporting overall company needs.
• Facilitate inspections and external audits/assessments to ensure the global Quality Management System is properly represented.
• Foster cooperation between teams to enable issue resolution.
• Serve as a facilitator and mentor to subordinates and fellow coworkers, retaining and building organizational talent.
• Mentor and develop the quality systems team through training, guidance, and support, fostering a collaborative and innovative work environment.
• Other duties as assigned

EXPERIENCE & EDUCATION

• Bachelor of Science in a Scientific, Technology, Engineering, Mathematics or related discipline; Master of Science degree preferred.

• 5-7 years of experience in quality within the medical device sector; at least 2 years in a leadership role with demonstrated progressive responsibility.

• Proven experience in managing ISO 13485 quality systems in a medical device or similar regulated company, including developing and implementing quality management systems complying with regulatory expectations worldwide.

• Demonstrated track record of ensuring compliance and successfully navigating regulatory audits.

• Experience supporting internal and external audits, including preparing audits, addressing findings, and implementing corrective actions to improve processes.

• Demonstrated ability to drive continuous improvement initiatives, such as Lean or Six Sigma, to enhance product quality and operational efficiency.

• Experience working with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to integrate quality systems into all aspects of product development and manufacturing.

• Must have training in ISO 13485 or demonstrate extensive experience with ISO 13485 and compliance with MDD, MDR, IVDD, IVDR and FDA quality system regulation.

KNOWLEDGE, SKILLS AND ABILITIES

Technical Knowledge and Abilities

• Fluent in Spanish and English

• Extensive knowledge of ISO 13485 and Regional requirements for Medical Devices

• Experience working with Notified Bodies, FDA and Health authorities

• Expertise in ISO 14971, including other relevant standards for embecta products

• Fluent in the use of global technology platforms such as Microsoft applications, SAP, or ETQ

• Knowledge of IVDR, MDR, MDSAP

• Strong leadership skills with experience in mentoring and developing quality teams, fostering a culture of quality and continuous improvement.

• Ability to manage multiple projects simultaneously, including planning, executing, and monitoring project progress to ensure timely completion

• Expertise in identifying and mitigating risks related to product quality and regulatory compliance.

• Professional communication and presence

• Ability to interface with and effectively communicate with a broad range of customers, cross functional teams, and executive management.

People Manager Core Competencies

• The ideal candidate will develop talent with integrity, transparency, and a focus on measurable outcomes. They will incorporate external perspectives, foster creativity, and collaborate effectively, ensuring inclusivity and continuous improvement. In organizational design and succession planning, they will maintain ethical standards, adapt to industry trends, and engage team members, promoting a culture of inclusivity. Effectively carries out the expectations of People Managers as defined in company’s people leadership expectations. Among others this includes maintaining regular, at a minimum once a month, and transparent communication with the team through effective use of formal one-on-one meetings with direct reports and team meetings. Managing performance issues and conflict proactively uses judgement in consulting with department leadership and Human Resources. Responsibility for the team´s compliance in terms of training, and fulfilment of their tasks and objectives as well as onboarding of new employees and development of the existing team

Customer Focus

• The ideal candidate will prioritize the customer's perspective in strategic decisions, craft service practices that meet customer needs, and continuously seek ways to improve satisfaction. They will encourage experimentation, collaborate with team members, and value diverse customer perspectives.

Decision Making

• The ideal candidate will gather and analyze information ethically, consider external data, and make timely decisions based on clear criteria. They will involve team members and ensure decisions reflect diverse perspectives.

Driving Innovation

• The ideal candidate will inspire ethical innovation, encourage novel solutions, and promote experimentation. They will foster a culture of creativity, collaborate to drive innovation, and ensure inclusivity.

Emotional Intelligence Essentials

• The ideal candidate will establish trusting relationships, accurately interpret emotions, and manage responses effectively. They will continuously improve emotional intelligence skills, build strong relationships, and ensure practices remain inclusive and respectful.

#LI-SS1

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 or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

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