Quality Analyst

• Ensuring that processes needed for the Quality Management System (QMS) are documented and identify the need for specific SOPs and ensures their application and update. To assurance that the electronic SOPs manual to meet the needs and requirements of regional QMS and local regulations.
• Reporting to top management on the effectiveness of the quality management system and any need for improvement.
• Administrate the activities of Quality Management System (QMS) to ensure compliance with the local, and international requirements and regulations to apply the Puerto Rico site, such as the FDA Medical Devices regulation & ISO 13485 standards.
• Ensure alignment of the local processes with global procedures; keep them updated in the document control electronic system, SmartSolve.
• Support the Document Control’s activities (document and change control, record retention, and translation) to ensure compliance with procedures.
• Administrate and keep updated all the documentation related to quality such as Complaints, Recalls or Field Actions, Quality Holds, NCRs, CAPAs, Management Review, Audits and execute all the tasks related to these processes.
• Manage set up, performance, and monitoring of Quality Training Matrix. Provide Quality trainings to new hires and existing personnel for areas of responsibilities to improve compliance.
• Assist in data entry, processing, and tracking of Complaints in the SmartSolve System (Pilgrim).
• Support the preparation and presentation of the Quality Management Review at least twice in a year.
• Support and execute the internal quality audit. Supporting the quality external inspections, as required.
• Support the quality activities in equipment calibration and preventive maintenance monitoring when apply.
• Maintain Quality Metrics/indicators databases to track performance and compliance and analyze data to develop and implement improvements to streamline and improve processes and procedures.
• Develops and distributes quality metrics reports and identifies issues and trends affecting compliance.
• Support compliance and process improvement initiatives for LATAM & Canada Region.
• Assurance the compliance of the quality objectives.

• Bachelor’s Degree, preferably in a science, business, or related discipline.
• Experience in manufacturing environment or equivalent.
• Basic knowledge of Quality Systems (CAPA, audits, Management Review, Quality Planning, etc.)
• Fluency in written and spoken English; French bilingualism preferred but no required.

• Inclusion, Diversity and Equity- Committed to Welcoming, Celebrating and Thriving on Diversity, Learn more about

• Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day
• Your Wellbeing: Medical, Dental, Employee Assistance Program, Parental Leave
• Flexibility: Hybrid Work Model (For most professional roles)
• Training: Hands-On, Team-Customized, Mentorship
• Extra Perks: Discounts and more!

Smith & Nephew