Note: It is possible for an individual to fill partly or multiple QE functions.
Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
- 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.
- Responsible for communicating business related issues or opportunities to next management level
- For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
- Performs other duties assigned as needed
EXPERIENCE AND EDUCATION
- 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 (2) years of experience in the QSR/ISO-regulated medical device operation desirable
REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS.
- 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
RESPONSIBILITY FOR OTHERS & INTERNAL INTERACTIONS
- Function as a project member in matters relating to Quality Engineering
- Utilize the safety and environmental regulations of the facility
- Position located in Norderstedt, Schleswig- Holstein, Germany.
- 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).
Company management reserves the right to add, delete or otherwise alter assigned duties at any time. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The minimum qualifications listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Johnson&Johnson Med GmbH (7930)