Manufacturing Quality Engineer in Norderstedt bei Johnson & Johnson

Johnson & Johnson Medical Devices, a member of the Johnson & Johnson family of companies is recruiting for the office in Norderstedt, Germany a:

Manufacturing Quality Engineer (m/f/d)

Fixed-Term (2 years) - Full Time or Part Time 80%

Location: Norderstedt (near Hamburg)

The Manufacturing Quality Engineer manages changes throughout the Life Cycle for launched products. As MQE you ensure compliance with company policies and procedures and recommendation involving the implementation of regulatory requirements. You utilize the Quality technical tools, process and system to support appropriate execution of the quality system. And with that you support risk management activities for product changes and guide for process changes and process deviations

Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, the MQE has the following:

Duties & Responsibilities

• Utilize Quality Engineering tools for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.
• Utilize quality engineering principles and problem-solving skills to develop and optimize products/processes that are aligned with the overall Quality and Business vision.
• Ensure effective risk management to prevent unanticipated failure modes and ensure capability.
• Develop, implement and maintain the appropriate Process Control Plan in alignment with Quality Plan.
• Ensure the development and validation of appropriate test methods for product and process performance, process controls and process risk management.
• Ensure effective quality strategies for validation.
• Lead and/ or support of CAPA´s
• Ensure effective and efficient use of Quality Engineering techniques such as risk analysis, test method development, statistical data analysis, statistical process control, and development of sample plans.
• Ensure effective change control
• Ensure active and thorough investigation of quality issues and effective corrective and/or preventive action.
• Support and maintain a state of inspection readiness.
• Are responsible for communicating business related issues or opportunities to next management level
• Are responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed

Qualifications

Qualification

• At a minimum, a BA/BS degree (BS Engineering preferred) or equivalent in a Life Science, Engineering, or Physical Science. Business Degree is desirable.
• Two years experience in the QSR/ISO-regulated medical device operation desirable

• Professional / Technical Experience in:
  • Packaging / Textile production / Metal production desirable
  • Statistical Skills (Green Belt or comparable)
  • Basic knowledge in Q-Systems, Regulatory (Design Control, Technical Files …)
  • Problem Solving
  • German, fluent
  • English, fluent
• Function as a project member in matters relating to Quality Engineering
• Utilize the safety and environmental regulations of the facility
• Less than 10% travel within region is required.
• This position will interact with outside organizations such as regulatory bodies (i.e. FDA,

ANVISA, etc.) and notified bodies (i.e. BSI).

We are offering you a diversified position with a variety of responsibilities in a dynamic and complex international environment. If you we have sparked your interest then please send us your complete online application (CV, Cover letter) in English.

What we offer

Our employees are just as important to us as our customers. At Johnson & Johnson, we like to think long-term and enable successful careers with interesting career paths within our company. We do everything we can to enable you to develop your full potential with us.

We are very proud of our open, appreciative corporate culture and value a healthy balance between work, family and leisure. Flexible working time models such as part-time, flexible time and home office can be adapted to your life. Our proactive health program and our company fitness center take care of your mental and physical well-being.

Working at Johnson & Johnson

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success