Quality Engineer II
hace 3 semanas
Johnson & Johnson is a world-leading healthcare company that transforms the history of health in humanity. We are committed to diversity and inclusion, and we welcome talented individuals from all backgrounds to join our team.
As a Quality Engineer II at Johnson & Johnson, you will play a critical role in maintaining high-quality standards for product manufacturing processes and ensuring compliance with regulatory requirements. You will administer Finished Goods Quality technicians and/or Quality Engineering technicians to support the Supply Chain, including project support, in day-to-day activities such as manufacturing lines, operator certification programs, incoming and finished good inspections, and CME environmental monitoring.
- Support quality improvement initiatives such as process and product characterizations that lead to continuous and cost improvements.
- Review and analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean techniques, and other improvement tools and programs.
- Conduct benchmarking with external companies or internal sites to develop more effective methods for improving quality.
- Support the development of quality engineering and quality compliance with the right skill sets for new product introductions and product life cycle management.
**Key Responsibilities:**
- Review and analyze whether current products and processes (including actions or decisions conducted) are in compliance with standards such as QSRs, ISO 13485, etc.
- Champion compliance to applicable global regulations and standards (e.g., QSRs, ISO, EN, and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.
- Conduct periodic line audits to assess for production controls such as lot segregation.
- Review results of area audits to ensure that corrective and preventive actions are adequate.
**Additional Responsibilities:**
- Support the development of quality strategies related to the transfer of products, materials, and components within J&J or externally.
- Support new product introduction as part of design transfer.
**What We Offer:**
- A dynamic and challenging work environment.
- Opportunities for career growth and professional development.
- A competitive salary and benefits package.
We are an equal opportunities employer and welcome applications from all qualified candidates. If you are a motivated and experienced Quality Engineer looking for a new challenge, please submit your application.
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