quality engineer // johnson & johnson à Neuchâtel

publié
contact
Andrea Oliveira, Randstad JnJ Neuchâtel Campus
type d'emploi
temporaire
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job details

publié
lieu
neuchâtel
secteur
administration
type d'emploi
temporaire
référence
136704-67
contact
andrea oliveira, randstad jnj neuchâtel campus
téléphone
032 934 90 38

description du poste

"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.

qualification

  • 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.