Johnson & Johnson Careers
Senior Quality Engineer
Requisition ID: 1905724027W
The Johnson and Johnson Family of companies is comprised of more than 250 operating companies in 57 countries employing approximately 128,000 people. Johnson and Johnson is the world ‘s most comprehensive and broadly based manufacturer of health care products, as well as a provider of related products for the consumer, pharmaceutical and medical devices & diagnostics markets. At least a billion people around the world are touched each day by what we do.
ETHICON Neuchâtel is responsible for the production of implants for the treatment of female incontinence and bio-resorption products to stop bleeding during surgical procedures. Ethicon is looking for a 9 months contract:
Senior Quality Engineer applies intermediate Quality Engineering/Scientific Method techniques and principles to daily tasks and activities. In this role, Senior Quality Engineer, will lead and/or support different activities for the EU MDR implementation and will report directly to the Plant Quality Manager at Ethicon Sarl. This is a great opportunity to acquire a deep knowledge about the new EU MDR regulations and be involved in its implementation form the beginning.
- Use quality engineering principles and problem-solving skills you will help to develop and optimize products/processes. Utilize statistical tools and techniques to establish sampling plans.
- Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvements.
- Develop and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
- Provide guidance to project teams and business partners to ensure compliance with company policies and procedures as well as medical device regulations.
- Supports the development of quality strategies related to the transfer of products, materials and components within J&J or externally. Supports new product introduction as part of design transfer.
- Monitor quality data and metrics on a regular basis to that ensure appropriate investigation, correction action, and/or escalation is conducted as required for recurring trends. Analyzes process-, product-, test-, Lab- and Quality Management System data and investigates for improvement opportunities.
- University/Bachelor’s Degree or Equivalent in Engineering or Science.
- Minimum of 4 years of experience in Quality and/or Compliance.
- Experience with ISO 9000, ISO 13485 and GMP, knowledge of product/process
- Green Belt or Black Belt certification is desirable.
- Quality and Statistical tools knowledge.
- Knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data in order to present data that facilitates/drives decision-making.
- Strong collaboration, communication, presentation and influencing skills required.
- Fluent in English, French would be an asset but not a requirement.
- Excellent organizational and communication skills (written and verbal).
- Ability to prioritize and manage multiple projects consisting of varying degrees of complexity.
- Ability to analyze complex problems and apply practical solutions.
- Can-do attitude and ability to take decisions are key.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
ETHICON Women's Health & Urology Sarl (8566)