At Medtronic, we are driven by our Mission to alleviate pain, restore health, and extend life. We are committed to improving lives through our innovative surgical products and solutions. Join us, and help us make a difference in the lives of patients worldwide.

A career at Medtronic is like no other. We’re purposeful. We’re committed. And we’re driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide. Join us as a valued team member at our Costa Rica, Alajuela, Manufacturing site. We look for accountable leaders who have a clear vision of where we are going and how to get there, bold inclusive thinkers who create new ideas and bring our best solutions forward to benefit our patients, business partners, and customers.

Bring your talents to an industry leader in medical technology and healthcare solutions – we’re a market leader and growing every day. You can be proud to be a part of technologies that are rooted in our long history of mission-driven innovation. You will be empowered to shape your own career. We encourage and support your growth with the training, mentorship, and guidance you need to own your future success. Together, we can transform healthcare.

Provide design quality engineering support in design and development of medical device products. Facilitate the application of design controls in product development and sustaining changes.

• Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
• Lead and mentor a team of Quality Engineers, Quality technicians and inspectors, fostering a culture of continuous improvement.
• Oversee daily quality operations, ensuring compliance with industry regulations and internal standards.
• Develop, implement, and monitor quality control processes to ensure the consistency and reliability of manufacturing operations.
• Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
• Collaborate closely with cross-functional teams including Engineering, Production, and Supply Chain.
• Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
• Lead root cause analysis investigations for any product non-conformities or process deviations.
• Implement corrective and preventive actions (CAPA) to address quality issues.
• Prepare and present detailed reports on quality performance to senior management.
• Ensure that all documentation meets regulatory requirements and is audit-ready at all times.
• Drive continuous improvement initiatives to enhance product quality and operational efficiency.

• Bachelor’s degree in Engineering, Quality Assurance, or a related field.
• Minimum of 6+ years of experience in quality engineering within the medical device manufacturing industry or related, or an advanced degree with a minimum of 3+ year of relevant experience.
• Strong knowledge of ISO 13485, FDA regulations, and other relevant quality standards.
• Advanced English (Bilingual English - Spanish Communication and Business Proficiency, and excellent written and verbal communication).
• Excellent leadership, communication, and interpersonal skills.
• Proficiency in statistical analysis tools and quality management software.
• Certification in Quality Engineering (CQE), Quality Management (CQM), or related certifications is preferred.
• Experience in manufacturing or quality engineering of medical devices.
• Experience using SAP/APO, or other ERP systems.
• Proficiency with MS Office (Excel, Power BI and Power Point focus).
• Ability to project possible future outcomes and scenarios based on available data.

• Good knowledge of ISO 13485.
• ISO 9001 Internal Auditor / Lead Auditor Cerification.
• ISO 13485 Internal Auditor / Lead Auditor Cerification.Lean Six Sigma Green Belt or Black Belt.
• Experience in leading a team and managing cross-functional teams like production, Quality or other, etc.
• Strong coaching and people leadership skills.
• Strong analytical, planning, Quality, regulation, and organizational skills.
• Proficiency in Project Management.
• Corrective and Preventative Action (CAPA).
• Strong decision-making ability.
• Good interpersonal and influencing skills

This position is eligible for a short-term incentive called the Operations Incentive Plan (OIP).