Senior Medical Device CSV & Quality Validation Specialist

Quality Consulting Group, LLC; Puerto Rico; On-site; USD 120,000 - 160,000; Full time

Job summary

QUALITY CONSULTING GROUP, LLC is seeking a talented Quality Engineer to join our team in Puerto Rico and the USA, focusing on compliant validation of IT systems and medical device regulations. You will coordinate with clients and cross-functional teams, lead FCA, CAPA, and documentation under FDA and international standards, and stay current with regulatory changes.

This role requires a Bachelor's in engineering or science and 10+ years in medical devices, with strong technical writing and

Qualifications

• Bachelor’s degree in Engineering or Science.
• 10+ years in the medical device quality/regulatory field.
• Experience leading FCA and CAPA processes.
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, EU MDR.
• Excellent written and verbal communication.

Responsibilities

• Conducts a compliant validation process for IT systems under federal regulations.
• Coordinates activities with clients, developers and personnel, domestic and global.
• Identifies requirements and maintains procedures to ensure regulatory compliance.
• Reports on validation status to fulfill regulatory requirements.
• Keeps abreast of changing federal and international regulatory requirements.

Skills

FDA regulations

CAPA

QMS

Cross-functional collaboration

Technical writing

DOE (with Minitab)

Software validation

IQ/OQ/PQ

Process validation lifecycle

SOP development

Change control

Education

Bachelor’s degree in Engineering or Science

Tools

Minitab

QMS software

Microsoft Office

Job description

QUALITY CONSULTING GROUP, LLC is seeking a talented Quality Engineer to join our team in Puerto Rico and the USA, focusing on compliant validation of IT systems and medical device regulations. You will coordinate with clients and cross-functional teams, lead FCA, CAPA, and documentation under FDA and international standards, and stay current with regulatory changes.

This role requires a Bachelor's in engineering or science and 10+ years in medical devices, with strong technical writing and