Quality Engineer // Johnson & Johnson

Job content

Caring for the world… one person at a time’ … inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo.

Johnson & Johnson is looking for their futur : Quality Engineer for 6 months

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.

Tasks & Responsibilities

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.
• 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.
  

Interpersonal Skills / Characteristics

• 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 would be a plus.
• Ability to challenge the status quo.
• Proven evidences of multi-tasking and proven evidences of taking ownership of action are required.
• Excellent problem solving, decision-making, 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.
  

Minimum Language Required

• French: fluency required.
• English: very good level required, fluency would be a plus.
  

If you are interested to join our team, please apply and send us your online application.