QA Manager – Medical Devices, FDA/ISO Compliance

Guerbet; Princeton (NJ); On-site; USD 120,000 - 180,000; Full time

Job summary

Guerbet is seeking a qualified QA Manager in Princeton, NJ to strengthen our quality management system. You will develop, review, and revise SOPs, ensuring compliance with FDA CFRs, ISO standards, and regulatory requirements for our medical devices and pharmaceutical products.

You will lead cross-functional teams to embed a strong quality culture, manage audits, CAPAs, regulatory inspections, and supplier qualifications while maintaining documentation and training aligned with corporate policies.

Qualifications

• Minimum of 8 years of QA experience in the pharmaceutical/medical device industry.
• Demonstrated expertise in FDA regulations and ISO standards.
• Experience with electronic quality management systems.
• Strong technical writing and process development skills.
• Previous consulting experience in SOP development.
• Proven experience in audit management and non-conformity resolution.

Responsibilities

• Develop and review SOPs to ensure compliance with CFR and ISO standards.
• Implement and maintain a local QA system aligned with group policies.
• Coordinate CAPAs and drive corrective actions with evidence.
• Support regulatory body inspections (FDA, state agencies).
• Oversee supplier qualifications and third-party contractors.
• Manage customer complaints, QA metrics, and quality risk assessments.

Skills

QA management

FDA regulations

ISO standards

Audit management

Technical writing

Process development

Regulatory inspections

Education

Advanced degree: Chemistry/Engineering/Life Sciences

Tools

Electronic QMS

Job description

Guerbet is seeking a qualified QA Manager in Princeton, NJ to strengthen our quality management system. You will develop, review, and revise SOPs, ensuring compliance with FDA CFRs, ISO standards, and regulatory requirements for our medical devices and pharmaceutical products.

You will lead cross-functional teams to embed a strong quality culture, manage audits, CAPAs, regulatory inspections, and supplier qualifications while maintaining documentation and training aligned with corporate policies.