Quality System Manager

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

Responsibilities

• Independently set up Quality Management Systems from scratch (FDA Site Registration, ISO13485 Certification
• HEAVY HEAVY HEAVY Medical Device Manufacturing/Plastic Injection Molding
• Lead, maintain, and enhance the company’s ISO 13485–compliant Quality Management System, ensuring alignment with FDA QSR and applicable global regulations.
• Drive and manage ISO 13485 certification, surveillance audits, and recertification cycles.
• Oversee and execute FDA Site Registration, and ongoing regulatory maintenance for the manufacturing site.
• Serve as the primary point of contact for regulatory bodies, notified bodies, and customer quality audits.
• Manage core QMS processes including document control, CAPA, nonconformance management, supplier quality, internal audits, training systems, and risk management (ISO 14971).

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/

The Company will consider qualified applicants with arrest and conviction records.