Quality Systems Analyst II (fix term until December 2026)

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:
Oberdorf, Basel-Country, Switzerland

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 a Quality Systems Analyst II located in Oberdorf (Basel Land), Switzerland.

This is a fixed term contract that will run until December 2026.

The Oberdorf Quality Systems Team is responsible for the compliance and continuous improvement of the site’s Quality System (QS).

In this role, you will work in a collaborative environment with various stakeholders and get hands-on experience with internal and external audits.

The Quality Systems Analyst II will drive the execution of the QS at the site level, including Nonconformances (NC), Corrective and Preventive Action (CAPA), Internal Audit (IA) Observations, Product Quality Escalation, Site Complaint Manufacturing Investigations, Quality Progress Review (QPR), Quality System Management Review (QSMR), and Records Management to ensure the QS meets all business and regulatory requirements.

You will also manage the performance and communication of Oberdorf QS metrics, as well as support site readiness in the deployment of QS initiatives.

As a Quality Systems Analyst, you will:


* Ensure consistent and correct execution of QS procedures at the site to maintain the quality and compliance of processes and records for NC, CAPA, IA Observations.

This includes, but is not limited to:
+ Review site CAPAs, NCs, IA Observations, Site Complaint Manufacturing Investigations, QPR and QSMR documentation
+ Assist with the development and documentation of problem statements, bounding, containment, risk assessments, investigation, and action plan determination (corrections, corrective actions, preventive actions, and effectiveness monitoring)
+ Ensure effective completion of activities
+ Provide guidance to record owners for appropriate documentation and compliant execution of procedures


* Coordination, preparation, facilitation, execution, and tracking of activities of the Quality Progress Review (QPR) and Quality System Management Rev...