Sr Manager, Supply Chain Quality EndoMech and Energy

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Quality

Job Sub Function:
Quality Systems

Job Category:
Professional

All Job Posting Locations:
Guaynabo, Puerto Rico, United States of America

Job Description:

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness.

Learn more at https://www.jnj.com/medtech

We are searching for the best talent for Sr Manager, Supply Chain Quality EndoMech and Energy to be in Guaynabo, Puerto Rico.

The Sr Manager, Supply Chain Quality EndoMech and Energy will support the Ethicon-Endo Surgery LLC (EES) Supply Chain Quality organization to transform the way we serve customers and patients with high-quality and compliant products each and every day into the future.

The Senior Manager is responsible to maintain a connection with the Quality Regulatory and Compliance and the Quality Excellence teams through strategies that drive continuous quality excellence, maintain supply chain compliance, providing Energy and Endomechanical platforms (Ethicon Endo-Surgery) support and addressing customer facing needs.

In addition, this leader will identify and implement key capabilities that will make Quality a competitive advantage by unlocking productivity and accelerating execution.

This role will be responsible for the management of the Quality Management System (QMS) of Ethicon-Endo Surgery LLC (EES LLC), Guaynabo site, and manage audits/inspections from Health Authorities, Notified Bodies, Johnson & Johnson, and customers and serve as the deputy Person of Responsible Regulatory Compliance (PRRC) for EES LLC legal manufacturer as per the EU MDR regulation.

Key responsibilities:


* Has oversight of the execution of the Quality Systems activities for EES LLC products.

These activities include but are not limited to CAPA, Non -conformances, Management Review, Internal Audit, Records Management, Document/Procedures review/approval and Quality Agreements in Compliance with applicable regulations and procedures.


* Assures systems are compliant to all applicable US and International Standards and Regulations such as GLP, GCP, GMP/QSR, MDD / EU MDR, EN (European Norm, harmonized standard for quality assurance in medical device manufacture), Canadian Medical Device Regulations, Japan PAL and ISO13485.


* Provides pre-and post-...