"Caring for the world… one person at a time” inspires and unites the people of Johnson & Johnson. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo.
The CAPA / NC site coordinator has the objective of implementing and maintaining high quality standards for the device development and product manufacturing process and compliance with all applicable regulatory requirements.
The CAPA / NC site coordinator is responsible for the overall functioning of the site’s CAPA and NC processes and represents the site in multi-site or franchise forums and projects. He/ she ensures and maintains a state of inspection readiness.
- Makes proposals and assists in the development of corrective action plans and monitors implementation
- Follows up on closure of corrective and preventive actions
- Develops and implements reports for quality data for Norderstedt and other plants if required
- Represent Norderstedt in any Franchise CAPA and NC forum
- Act as SME for internal and external audits for CAPA and NC processes
- Coordinate and improve CAPA and NC training activities, including new user training
- Develop and monitor critical metrics for the CAPA and NC processes and coordinate accurate actions to drive improvements
- Conducts investigations, collects data, analyzes trends and prepares reports for assigned quality processes
- Has detailed understanding of process criteria and regulations and business impact of decisions and actions
- Leads and participates in quality improvement initiatives and projects
- Compile data and prepares reports on system effectiveness for management
- Leads and supports CAPA and NC continuous improvement and simplification activities (Lean)
- Prepares and leads data review board meetings and internal audits
- Leads CAPA’s or NC’s as required
- Responsible for communicating business related issues or opportunities to next management level
- At a minimum, a BA/BS degree or equivalent in a Life Science, Engineering, or Physical Science Master’s degree in a Technical or Science field preferred
- Two to five years of related experience in a World Class Manufacturing environment
- Strong background in NC, CAPA and audit process as well as quality data reporting and review
- Strong background in Process Excellence, Lean methodologies or operational excellence preferred
- Experience in program and project management processes and tools preferred
- Solid financial skills, including strategy and business case development, budgeting and business planning processes preferred
- Strong background in Good Documentation Practices
- Advance computer skills and use of software applications
- Statistical and analytical problem solving
- Quality Mindset, Verbal and written communication skills, Teamwork, Cooperativeness, Customer Focus, Reliability, Sense of Responsibility, Accountability, Openness for Change and Problem solving are desirable kills
- Fluent in German and English
This role is subjected to the Chemical tariff contract policy of North Germany, tariff part E12-13.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. 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)