Johnson & Johnson Karrieren
Senior CAPA Engineer (m/f/d) – Multiple Location
Requisition ID: 00001EKD
You will support the CAPA process through data analysis, assurance of robust CAPA failure investigation and content, collaborating with the CAPA Complaint Councils, monitoring of CAPA process metrics and serving as a coach and advocate for the CAPA process, while constantly seeking continuous improvement opportunities. You will work across the EMEA Ethicon Franchise to support the harmonization and integration of an optimized Ethicon CAPA process.
Are you ready to work doing something you are passionate about?
This position may be placed at any JnJ EMEA site.
- Support the overall management and effectiveness of the CAPA process for the Medical Device businesses
- Provide direction and mentoring for CAPA Site Leaders and CAPA owners as needed, resulting in each site successfully implementing, maintaining and improving the CAPA process
- Provide ongoing education for the CAPA process; develop and implement measures to monitor the effectiveness of the CAPA process and drive remediation for improvement where necessary
- Maintain regular interface with Management to achieve company’s Quality goals.
- Responsible for communicating business related issues or opportunities to next management level.
- Develop proactive and collaborative working relationship across key functions, including R&D, Quality Ops, Supply Chain and others, delivering results within the matrixed organization
- Serve as a subject matter expert for CAPA process. This position will support front and back room audits activities and ensure process compliance with the requirements of all relevant internal and external standards, policies and regulations.
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
We believe we can make a difference and we take your career seriously and your development is key and our day-to-day responsibility. Through e-university, on the job training, various projects and programs, we ensure your personal growth.
If you enjoy solving hard problems, you're a self-starter and you're passionate about your career every single day, we'd love to hear from you!
- A minimum of a Bachelor's degree is required, a degree concentration in Engineering, Life Science, Physical Science or a related field is preferred; an advanced degree is an asset
- A minimum of 6 years of work experience in the medical device, pharmaceutical or other highly regulated industry is required
- Experience in dealing with audits / inspections with the FDA, other notified bodies or any other Health Authority
- Demonstrated skills in root cause analysis and failure investigation are required
- Knowledge of Good Manufacturing Practices (GMPs) and ISO policy and procedures are required
- Demonstrated project management skills, such as supporting multiple projects simultaneously are required
- Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is preferred
- Speaking and writing in English is mandatory for this position + another language is an asset
- This position may be located at any JnJ EMEA site and will have up to 10% international Travel
Johnson & Johnson is an equal opportunity employer. We value diversity at our company. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Johnson&Johnson Med GmbH (7930)