Johnson & Johnson Karrieren
Customer Quality Manager (m/f) ETHICON – Dülmen or Norderstedt
Requisition ID: 1805687589W
Johnson & Johnson Medical Companies produce a broad range of innovative products and solutions used primarily by health care professionals in the fields of orthopedics, neurological disease, infection prevention, cardiovascular disease, and aesthetics. As the most comprehensive devices business in the world, Johnson & Johnson Medical Devices is best suited to serve evolving customer needs, train more surgeons to improve standards of care, and treat more patients globally as access expands.
ETHICON & CSS Centre of Excellence (COE) for Vigilance is a Customer Quality organization that supports numerous businesses across Johnson and Johnson companies in the field of Medical Device Vigilance. The Vigilance COE aims to deliver an efficient, effective and compliant health Authority reporting with EEA, Switzerland and Turkey in accordance with local regulations.
You are primarily responsible for the oversight of complaint file review and Medical Device Vigilance Reporting elements of the Customer Quality Process. You will supervise the Ethicon Endo Surgery Medical Device Vigilance team and will serve as a primary back up for the Senior Manager in the COE.
- Execute Medical Device Vigilance Decisions in accordance to MED DEV 2.12-1 and governing Medical Device Regulations for assigned business units
- Submission of Medical Device manufacturer’s incident reports in line with timeframes described in MED DEV 2.12-1 and governing Medical Device Regulations for assigned business units
- Support your employees as consultant, coach and mentor and ensure that everyone in your team can develop according to their strengths and interests
- You drive the development of next generation processes and procedures to provide customer valued feedback (clinicians, authorities) and maintain high level of compliance
- You build and manage relationships with important internal and external partners
- You encourage the collaboration and interaction with other site teams, including teams representing production, research and development, product management and supplier quality
- You lead communication with Health Authorities in written and/or verbal form
- Professional experience within a regulated medical device environment and several years in complaint handling is preferred, ideally in a Medical Device Vigilance team
- Experience in leadership and development of teams preferred
- Experience in project management and knowledge of relevant tools
- Fluency in English both spoken and written
- Ability to communicate information and system & process requirements with appropriate individuals in a clear, concise & effective manner
- Applicable knowledge of Quality, FDA (Food & Drug Administration), MDD, MDR & ISO (International Organization for Standardization), HIPPA (Healthcare Information Patient Privacy Act) Requirements
The well-being and development of our employees are central aspects of our company creed. Individuals who would like to fully realize their potential as part of our international, innovation-driven corporate family and who aspire to have challenging work, will find that our company provides just the right conditions. We consider intensive initial training, further education that is tailored to our employees' work and excellent opportunities for development - both nationally and internationally - to be just as essential as a good work-life balance, attractive compensation and above-average employee benefits. One aspect that distinguishes our company is the large number of measures we have to support our trainees and promote career development in ways that are also compatible with family life.
Ethicon Endo-Surgery G.m.b.H. (7955)