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
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.
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.