About this opportunity
Entegee lists this Quality System Manager opportunity in west caldwell, New Jersey. Review the employer’s description below for duties, qualifications and application requirements.
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
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The Company will consider qualified applicants with arrest and conviction records.
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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.