Senior Manager, Quality Systems

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.

We provide an inclusive work environment where each person is considered as an individual.

At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:
Quality

Job Sub Function:
Quality Systems

Job Category:
People Leader

All Job Posting Locations:
Anasco, 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 Senior Manager, Quality Systems to be located in Añasco, PR.

Purpose:

Lead the design, implementation, maintenance, and continuous improvement of the site Quality Management System (QMS) to ensure compliance with applicable regulations and corporate quality standards.

Act as a subject matter expert for Quality Systems across development, manufacturing, and supply chain activities, enabling product quality, patient safety, and regulatory readiness.

Key responsibilities:


* Own and continuously improve the QMS (policies, SOPs, work instructions, records) to align with cGxP expectations and corporate requirements.


* Lead CAPA, nonconformance, deviation, change control, complaint handling, and recall readiness processes; ensure timely investigation, root-cause analysis, and effective remediation.


* Develop and maintain a risk-based approach to quality (FMEA, QRM) and integrate risk management into product and process decisions.


* Oversee internal and supplier audit programs; plan, coordinate, and lead internal and external audits and ensure timely closure of findings.


* Support supplier qualification and ongoing supplier quality oversight, including audits, performance monitoring, and corrective actions.


* Ensure effective document and record control, release processes, and electronic QMS (eQMS) utilization and optimization.


* Provide quality support for manufacturing transfers, scale-up, technology transfers, and process validation/changes.


* Coach and mentor site quality teams and cross-functional partners on quality system expectations, investigations best practices, and compliance culture.


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