Manufacturing Quality Engineer (m/w/d) in Vollzeit oder Teilzeit (80%)

Interne Stellenausschreibung 25.01. – 08.02.2023  

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)

Full Time or Part Time 80%

Location: Norderstedt (near Hamburg)

The Manufacturing Quality Engineer is managing changes throughout the Life Cycle for launched products. He / she ensure compliance with company policies and procedures and recommendation involving the implementation of regulatory requirements. He /she utilize the Quality technical tools, process and system to support appropriate execution of the quality system. And with that he / she 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

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