Manufacturing Quality Engineer (m/f/d)

at  Johnson Johnson

“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

JOB SUMMARY

The Manufacturing Quality Engineer (MQE) is managing changes throughout the Life Cycle for launched products. A MQE ensure compliance with company policies and procedures and recommendation involving the implementation of regulatory requirements. Utilize the Quality technical tools, process, and system to support appropriate execution of the quality system. And with that the MQE supports 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, you have following:

QUALIFICATION

• At a minimum, a bachelor’s degree or equivalent in Engineering, Life Science, Pharmacy or Physical Science
• Two years’ experience in a regulated healthcare industry (pharmaceuticals, medical device, biologics, or equivalent) is desirable
• Professional / Technical Experience in:
• Manufacturing and sterilization environment desirable
• Statistical Skills (Green Belt or comparable) desirable
• Basic knowledge in Quality and Regulatory framework
• Problem Solving skills
• German, fluent
• English, fluent
  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.

• 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
• Functions as a project member in matters relating to Quality Engineering
• 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
• Utilize the safety and environmental regulations of the facility
• Is responsible for communicating business related issues or opportunities to next management level
• The position will interact with outside organizations such as health authorities (e.g. FDA,
• ANVISA, etc.) and notified bodies (e.g. BSI)
• Is responsible for ensuring personal and company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed