Senior Quality System Engineer.

Job content

Caring for the world… one person at a time” inspires and unites the people of Johnson & Johnson. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo.

DePuy SynthesCompanies of Johnson & Johnson is the largest, most comprehensive orthopedic and neurological business in the world. DePuy Synthes offer an unparalleled breadth and depth of technology, devices, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, cranio-maxillofacial, power tools and biomaterials. Our broad array of inspired, innovative and high-quality offerings, help advance the health and wellbeing of people around the world.

We Are Looking For a Highly Committed

Senior Quality System Engineer based in Le Locle

(Permanent)

Overview

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.

Further Responsibilities And Duties Are

Quality System Management Review (QSMR) facilitator

• Prepare Franchise QSMR: Ensure logistic of meeting, collect the data and information, ensure analyze of data and compliance with QSMR procedures and assist the management representative during the meeting by creating the meeting minutes and other document required per procedure.
  
  

Global Supply Chain (GSC) support

• Responsible for the consistent and correct execution of Quality System 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 the progress; and elevating issues for resolution.
• Manages on site the timely collection, escalation and reporting of all Quality System metrics to management.
• Maintains original documentation for site NC, CAPA, Audit Observations, Product Quality Escalation and QSMR as quality records.
• Identifies site needs to meet and improve system performance of NC, CAPA, Audit Observation, Product Quality Escalation and QSMR at the site level, and escalates to appropriate representative and management in a timely manner.
• Ensures quality systems are effectively deployed.
• Leads and participates in quality system improvement initiatives.
• Determines root causes of quality issues and develops corrective action and recommendations for any compliance issues for GSC base business activities.
• Reviews processes change recommendations, as appropriate.
• Establishes, maintains, and implements communications to increase awareness and promote improvement of quality issues across the business.
• Supports compliance activities by participating in audit readiness; assists in Internal and External audits; serves as Subject Matter Expert for NC, CAPA processes.
• Assists with external audits, generating reports with corrective action plans and ensuring implementation of corrective actions in a timely fashion.
• Ensure external and internal audits preparation (strategy level).
  
  

Regulatory support

• Ensures consistent and correct execution of Quality System - Regulatory procedures at the site to maintain the quality and compliance of the processes and the records of regulatory documentation provision. This includes:
• Support to provide regulatory documentation for registration purpose (documentation requests, legalization, …)
• Collaborate with affiliates and support US RA departments to make sure that the requested documents are complete, accurate and provided in a timely manner
• Coordinate regulatory shipping restrictions process and quality restrictions
• Review related procedures
  
  

Qualifications

• University/Bachelor’s Degree or Equivalent Knowledge / experience of medical or technical industry.
• 4 to 5 years of professional work experience within a quality assurance or compliance audit environment is required. Experience working in a Medical Device manufacturing environment is preferred.
• Prior experience of External Regulatory and/or Notified Body Inspections (e.g. FDA, BSi etc) is preferred.
• Ability to communicate at different levels of the organization, and to interact with and influence cross-functional and cross-business teams to drive results (negotiation skills).
• Conscientious / Rigorous / Analytical Mind.
• Well organized and systematic approach.
• Knowledge of Microsoft Office tools.
• French: fluent
• English: fluent
  
  

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.

That is why we in Switzerland are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!

If you want to be a change agent in a challenging environment and shape the future quality organization, please send us your online application (CV, Motivation Letter, Working References etc.).

Primary Location

Switzerland-Neuchâtel-Le Locle-

Organization

Medos International Sarl (7898)

Job Function

Quality

Requisition ID

2206009150W