Quality IT & Compliance Specialist (Medical Devices)

Quality Consulting Group, LLC; Northern (KY); Hybrid; USD 120,000 - 150,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a seasoned quality validation specialist to join our team, contributing to world-class manufacturing in the US. You will lead compliant validation of IT systems, document SOPs, and coordinate with clients, developers, and operations domestically and internationally.

The role requires deep knowledge of FDA regulations (21 CFR Part 820), ISO 13485 and EU MDR, with strong communication and technical writing skills.

Qualifications

• Bachelor’s degree in Engineering or Science required.
• 10+ years in medical device quality and regulatory compliance.
• Proven experience with FCA/CAPA and FDA (21 CFR Part 820).
• Strong technical writing and cross-functional collaboration.
• Experience with IQ/OQ/PQ and CSV validation activities.

Responsibilities

• Conducts a compliant validation process for quality IT systems with proper documentation.
• Coordinates activities with clients, programmers/developers and personnel domestically and globally.
• Identifies requirements for compliant computerized operations and maintenance procedures.
• Reports on validation status to fulfill regulatory requirements.
• Keeps abreast of regulatory changes and audit policies.

Skills

Communication skills

Interpersonal skills

Technical writing

Education

Bachelor’s degree in Engineer or Science

Tools

QMS

Microsoft Office

CSV

Minitab

Job description

Quality Consulting Group, LLC is seeking a seasoned quality validation specialist to join our team, contributing to world-class manufacturing in the US. You will lead compliant validation of IT systems, document SOPs, and coordinate with clients, developers, and operations domestically and internationally.

The role requires deep knowledge of FDA regulations (21 CFR Part 820), ISO 13485 and EU MDR, with strong communication and technical writing skills.