Senior Quality Systems 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:
Quality Systems

Job Category:
Professional

All Job Posting Locations:
Le Locle, Neuchatel, Switzerland

Job Description:

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

Senior Quality Systems Engineer

Responsible for the execution of Quality Systems (QS) at legal manufacturer level, including Nonconformances (NC), Corrective and Preventive Action (CAPA), Audit Observations, Product Quality Escalation, Quality System Management Review (QSMR), regulatory submission support and other assigned QS activities to ensure systems are effective and in compliance.

Manage the performance and communication of QS metrics at legal manufacturer level.

Support Regulatory activities related to internal registration, including regulatory registrations and Regulatory shipping restrictions, on-site administration of the processes to ensure all business and regulatory requirements are met.

Oversight the supplier management process on behalf of the Legal Manufacturer including but not limited to the participation to supplier verification audit and review and follow up of potential related observation, and to the management and sustaining of the legal manufacturer approved supplier list and associated critical supplier list.

Duties & responsibilities

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position is responsible for the following activities:

Quality system:



* Responsible for the consistent and correct execution of QS procedures at the site to ensure the quality and compliance of processes and records for NC, CAPA, Audit Observations, Product Quality Escalation and QSMR,


* Responsible for the timely and compliant execution of site NCs, CAPA, Audit Observations, Product Quality Escalation and QSMR, by championing cross-collaboration across functions, sites, and operating companies; identifying barriers for th...