Quality 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

Quality Engineer based in Neuchâtel

(1 year fix term)

Position Overview

The Quality Engineer II will utilize Quality Engineering tools and practices for the effective and efficient development, maintenance, optimization and sustaining of the global Non-Conformity process as priority. He or she will also utilize Quality Engineering and problem-solving skills to improve and maintain product/processes that are aligned with the overall Quality and Business. While supporting operation in Base Business production, he/she will use risk management tools to prevent unanticipated failure modes and improve capability of the different processes.

Further Responsibilities And Duties Are

Production/Process Controls

• Partners with J&J Global Supply Chain to ensure appropriate application of process validations, process controls and risk management.
• Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
• Collect data and execute/conduct various analytical/statistical analysis and interpretations as part of process improvements and day-to-day activities.
• Assess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis.
• Assess and interpret common versus special causes of variation in manufacturing processing.
• Support Operation when challenges happen in day-to-day production, participate/lead investigation and strategy to removes theses challenges while maintaining the highest quality standards of the products.
• Support and collaborate closely with Incoming Inspection department by providing technical expertise on components, finished products and their associated inspections.
  
  

Product Quality, Control & Disposition

• Supports activities related to the Material Review Board.
• Support/conduct investigation, bounding, documentation, review and approval of non-conformance and CAPA.
• Supports complaint analysis when needed.
• Escalation of quality issues as appropriate.
• Analyze/review/conduct action or effectiveness of CAPAs. Review root cause investigation according to an established process.
• Accountability of Quality Metrics.
  
  

Product/Process Qualification

• Approve/write, if needed, IQ, CSV, OQ, PQ, Test Method Validation, Validation Plans and Validation reports.
  
  

Risk Mitigation

• Document, justify, review or analyze whether a proposed change to a process will not enhance the risk and generate adverse effects to the process or to the patient.
• Support/lead risk implementation or update of risk management tool as (but not limited to) pFMEA.
  
  

Compliance / Regulatory

• Review/analyze whether current products and processes (including actions or decisions conducted) are in compliance to standards such as QSR, ISO 13485, MDR, MDSAP.
• Champions compliance to applicable Global Regulations and standards, including support during internal or external audits.
  
  

Qualifications

• A minimum of a bachelor’s degree, preferably in Engineering or related technical discipline, is required.
• A minimum of 2 years of experience in quality is required, ideally in a Medical Device company. 4 years minimum of experience in a Medical Device company would be an asset.
• Knowledge of Microsoft Pack Office and statistical software packages is preferred with the ability to preview, graph and analyze data and present data that would facilitate / drive decision making process.
• Good technical understanding of manufacturing equipment and processes would be a plus.
• Experience working in both an FDA and European regulatory environment is preferred.
• Working knowledge of GMPs, QSR, 21 CFR 820, MDD, MDR, ISO13485 and ISO14971 is preferred.
• Working knowledge of CSV would be a plus.
• Process Excellence (6 Sigma or Lean) training required, certification would be a plus.
• Experience with a proven track record of implementing appropriate risk mitigation.
• Knowledge and experience in reading technical drawings and associated measurement, including GD&T standard, would be an asset.
• Ability to “think out of the box”, flexibility, open-minded, team spirit and “can do” attitude are required personal skills.
• Good technical understanding of manufacturing processes is required, ideally with human-based manufacturing processes.
• Ability to challenge the status quo.
• Proven evidence of multi-tasking and proven evidence of taking ownership of action are required.
• Excellent problem solving, decision-making based on risk evaluation, and root cause analysis skills are required.
• Ability to understand customers’ needs and to develop method that will bring global improvement for the entire Business Unit.
• Experience in working in a multi-cultural environment
• French: fluency required.
• English: very good level required, fluency would be a plus.
  
  

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 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-Neuchâtel-

Organization

Medos Sarl (8575)

Job Function

Engineering

Requisition ID

2206044240W