Process Quality Specialist

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We are seeking talented individuals for the Process Quality Specialist position located in San Lorenzo, PR.

About MedTech

Driven by innovation at the intersection of biology and technology, we develop smarter, less invasive, and more personalized treatments. Learn more at .

Key Responsibilities

• Lead investigations and rapid response teams (RRT) for negative trends, quality/product process investigations, and product complaints.
• Provide technical leadership to identify causes of non-conformances and process failures, and implement corrective and preventive actions.
• Review and analyze quality trends with manufacturing teams, guiding process improvements and investigations.
• Support manufacturing supervisors and support groups in conducting thorough investigations.
• Manage internal audits, including observations and corrective actions.
• Analyze data, identify trends, and recommend actions for process, equipment, and system improvements.
• Write procedures, protocols, and documentation to enhance processes and systems.
• Provide training on tools for process evaluation and enhancement, such as analytical troubleshooting, FMEA, and statistical concepts.
• Lead CAPA initiatives and recommend actions based on negative trends.
• Ensure compliance with environmental, safety, and occupational health policies (ISO14001 & OSHAS 18001).

Qualifications

Education: Bachelor's degree required.

Experience and Skills:

• At least 2 years of relevant work experience.
• Availability for various work schedules, including shifts and weekends.
• Bilingual in Spanish and English.
• Knowledge of QSR, GMP, ISO, failure mode analysis, and problem-solving techniques.
• Strong negotiation, leadership, teamwork, and interpersonal skills.
• Willingness to work irregular hours and visit multiple shifts and locations.

Additional Information

• Position may be based in San Lorenzo or Manatí, PR, depending on operational needs.
• 10% travel required, domestically and internationally.

Johnson & Johnson is an Equal Opportunity Employer. We support inclusive hiring and accommodations for applicants with disabilities.