Senior Quality System Manager – ISO 13485 & FDA

Entegee; West Caldwell (NJ); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Term life insurance

Short-term disability insurance

401K plan

Commuter benefits

Job summary

Entegee is seeking an experienced Quality Management Systems leader to independently set up and maintain an ISO 13485–compliant QMS for a medical device manufacturing site in New Jersey. You will own FDA site registration, audits, and ongoing regulatory maintenance, while coordinating with notified bodies and customers.

The role requires deep expertise in ISO 13485, FDA QSR, and ISO 14971 risk management, with a track record of leading successful certifications and surveillance.

Qualifications

• Experience building or leading ISO 13485 QMS for medical device manufacturing.
• Proven track record with FDA site registration and QSR compliance.
• Strong CAPA, supplier quality, and internal audit experience.

Responsibilities

• Set up and maintain ISO 13485 compliant QMS from scratch.
• Lead FDA site registration and regulatory maintenance for the site.
• Coordinate audits by regulatory bodies and customers.
• Manage core QMS processes including document control, CAPA, nonconformance, supplier quality, internal audits, training, and risk management.

Skills

ISO 13485

FDA QSR

Regulatory compliance

CAPA management

Internal audits

Risk management (ISO 14971)

Documentation control

Education

Bachelor’s degree in Engineering or related field

Tools

Document control systems

CAPA tracking tools

Job description

Entegee is seeking an experienced Quality Management Systems leader to independently set up and maintain an ISO 13485–compliant QMS for a medical device manufacturing site in New Jersey. You will own FDA site registration, audits, and ongoing regulatory maintenance, while coordinating with notified bodies and customers.

The role requires deep expertise in ISO 13485, FDA QSR, and ISO 14971 risk management, with a track record of leading successful certifications and surveillance.