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Senior Quality Manager, Document Control and Training at Integra LifeSciences - ApplyBlast

Senior Quality Manager, Document Control and Training

Integra LifeSciences

4 months ago

3.1 on Glassdoor

Princeton, NJ

Onsite

Full Time

Senior

0 applicants

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About this role

A Senior Quality Manager leads the Quality Management System (QMS) team to design, implement, and oversee compliance strategies for document control, change management, and training administration in medical devices. The role ensures adherence to global regulations such as FDA standards, ISO 13485, and EU Medical Device Directives while driving continuous improvement across manufacturing facilities.

Responsibilities

Lead the Quality Management System team to implement compliance strategies.
Oversee document control and training administration programs globally.
Ensure adherence to FDA, ISO, and international regulatory requirements.
Drive standardization and deploy solutions for improved quality processes.
Evaluate new regulations and implement plans to maintain compliance.

Skills

Qualifications

Bachelor’s Degree in Science or Engineering10+ Years in Medical Device/Pharmaceutical Industry7+ Years of Management ExperienceProficiency in QMSR/GMP RegulationsKnowledge of ISO Standards