Medical Device Quality & Validation Lead

FITS LLC; Villalba (PR); On-site; USD 80,000 - 110,000; Full time

Job summary

FITS LLC seeks an experienced Quality Assurance professional to lead validation and CAPA activities in medical device environments. This role focuses on IQ/OQ/PQ, DOE, and compliant validation of quality IT systems, working with cross-functional teams in the US and internationally.

You will collaborate with clients, developers, and operations, ensure regulatory compliance (FDA 21 CFR 820, ISO 13485, EU MDR), and drive continuous improvement through robust documentation and problem-solving.

Qualifications

• Bachelor's degree in Engineering or Science with eight years in Medical Devices industry.
• Bilingual in Spanish and English.
• Experience in field corrective actions, CAPA, or product quality management.
• Shift: 1st shift.

Responsibilities

• Conducts a compliant validation process for quality information technology systems, which requires formal validation documentation.
• Coordinates activities with clients, programmers/developers, and operating personnel, domestic and, as appropriate, global.
• Identifies current and anticipated requirements for compliant computerized operations and suggests methods to identify, implement, and maintain the procedures.
• Reports on the status of validation activities to fulfill regulatory requirements.
• Keeps abreast of changing federal and international regulatory requirements, government audit policies, and the availability of current techniques.
• Performs system administration and configuration of quality information technology systems.
• Quality role to support product transfer activities, focus on sterilization machines, validation, and process.
• Experience with process failure mode analysis and first-time quality.
• Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, EU MDR, and other relevant medical device regulations.
• Proven experience leading FCA and CAPA processes, ideally within a medical device or regulated industry.
• Strong project management skills, with the ability to manage multiple priorities and deadlines. Excellent problem-solving and analytical skills, with the ability to identify root causes and implement effective corrective actions.
• Outstanding communication and interpersonal skills, capable of effectively working with cross-functional teams and external stakeholders.
• Proficiency in quality management systems. Strong technical writing capability.

Skills

Bilingual: Spanish and English

Teamwork

Project management

Analytical/problem-solving

Technical writing

Education

Bachelor's Degree in Engineering or Science

Job description

FITS LLC seeks an experienced Quality Assurance professional to lead validation and CAPA activities in medical device environments. This role focuses on IQ/OQ/PQ, DOE, and compliant validation of quality IT systems, working with cross-functional teams in the US and internationally.

You will collaborate with clients, developers, and operations, ensure regulatory compliance (FDA 21 CFR 820, ISO 13485, EU MDR), and drive continuous improvement through robust documentation and problem-solving.