Electrophysiology Quality Director

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 https://www.jnj.com

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About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

About Cardiovascular

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for Electrophysiology Quality Director.

Purpose:

The Director, Quality Assurance is responsible for overseeing the quality management framework at Johnson and Johnson MedTech Costa Rica to ensure compliance with regulatory requirements and industry standards. This leadership position involves developing, implementing, and maintaining quality assurance practices that guarantee the production of safe and effective medical devices.

Key responsibilities include leading the site’s quality assurance team, hosting external inspections from health authorities and notified bodies and coordinating response actions for any non-conformities. The Site Quality Director plays a vital role in driving continuous improvement initiatives through data analysis, trend identification, and the implementation of corrective and preventive actions.

You will be responsible for:

In alignment with all federal, state, and local laws and Johnson & Johnson corporate guidelines, your responsibilities will include:

• May serve as the Management Representative and/or Head of Quality for the Site, as needed.
• Analyzing and presenting information related to business conditions, production capacities, and quality indicators.
• Overseeing the formulation of operational policies and procedures to ensure compliance and optimize quality systems.
• In partnership with the Quality System Leader, oversees the execution of activities such as CAPA, Nonconformance, Training, Change Control, Supplier Quality.
• Supports the implementation and updates of digital systems that support the business framework.
• Creating and refining product assurance programs, detailing roles, responsibilities, and operational procedures.
• Evaluating product assurance reports and collaborating with management to inform budgetary decisions.
• Partnering with Regulatory Compliance to guarantee adherence during internal and external audits.
• Organizing and managing quality projects in line with company objectives.
• Facilitating the professional development and training of your team members.
• Forecasting staffing and resource needs based on project priorities.
• Communicating business-related issues and opportunities to upper management.
• Ensure that team members adhere to Company health, safety, and environmental standards while providing the necessary resources for compliance.
• Performing additional duties as assigned.

Qualifications / Requirements:

• University bachelor’s degree in a relevant field. A Master’s degree in a related field is preferred.
• A minimum of 10 – 12 years of applicable experience, preferably within the Medical Device Industry.
• Strong understanding of relevant standards and regulations.
• Proven experience in multinational environments and managing significant projects.
• Demonstrated ability to lead high-performing, cross-functional teams.
• Experience with FDA or other Health Authority inspections is essential.

• Deep knowledge of laws and standards related to medical device manufacturing.
• Ability to analyze and interpret complex documents.
• Skilled at handling sensitive inquiries and complaints effectively.
• Proficient in delivering persuasive presentations on complex topics to a variety of audiences, including top management.
• Strong problem-solving abilities, including data collection and analysis.
• Experience interacting with government representatives.
• Leadership and management capabilities, especially within the context of regulatory compliance.
• Proficiency in Advanced Quality Systems.
• Excellent communication and interpersonal skills.
• Strong analytical and statistical problem-solving skills.
• ASQC certifications are preferred but not required.
• Bilingual proficiency in English and Spanish is a plus.

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