Source Quality Engineer

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:
Supplier Quality

Job Category:
Professional

All Job Posting Locations:
Le Locle, Neuchatel, 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 Source Quality Engineer to be in Neuchatel.

Purpose:
The Site Source Quality Engineer serves as the on-site Johnson & Johnson Medical Devices (JJMD, hereafter represented by Synthes GmbH and Medos International SARL) quality engineering representative for the Strategic Collaborator (SC).

In collaboration with the SC, he/she utilizes quality engineering principles and problem-solving skills to improve and maintain JJMD products and processes.

He/she supports the SC quality engineering team on initiatives impacting JJMD products and processes, by providing guidance in validation, risk management, product quality issue resolution and escalation, and quality systems performance monitoring.

The Source Quality Engineer is responsible for ensuring that the SC has a clear understanding and ability to execute to the JJMD/SC Quality Agreement requirements, J&J Policies, and applicable regulations and standards.

You will be responsible for:
·    Reviews and approves key quality records related to JJMD products in accordance to the Quality Agreement (QA) and Quality System Execution Plan (QSEP) as per Change Control process. 
·    Coordinates JJMD review of Non-routine Rework and Use-As-Is nonconformance disposition in collaboration with other required JJMD functions.
·    Reviews high-risk CAPAs (i.e.

Field Action, Critical Audit Observations, Major External Audit Observations, Near Misses and PRM). 
·    Partners with the SC to assess nonconformances resulting from the Product Release Monitoring (PRM) process. 
·    Approves nonconformance investigations resulting from PRM process. 
·    Track & Trends PRM data and communicates any negative trend to the JJMD and SC Quality Management. 
·    Supports SC Quality and Manufacturing Engineering on the resolution of quality issues impacting JJMD products and coordinates additional subject matter expert support needed from JJMD. 
·    Supports improv...