Johnson & Johnson Careers
Requisition ID: 1805683224W
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.
As part of the ETHICON and CSS Centre of Excellence for Vigilance organization the complaint analyst will product complaints received through various communication modalities and contribute to complaint management system in accordance with internal and external complaint handling procedures while demonstrating world-class customer support. EMEA CQ analysts’ s focus is Vigilance reporting per Regulation (EU) 2017/745 and MED DEV 2.12-1 and management of Health Authority requests.
For our production site in Le Locle we are currently looking for a
Complaint Anaylst (M/F)
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position will:
- 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 accordance to timelines outlined in MED DEV 2.12-1 and governing Medical Device Regulations for assigned business units
- Responding to Health Authority questions
- Executing Complaint Management process in accordance to established procedures
- Show positive initiative and ability to deal with ambiguity; in team situations, coordinate issues with peers.
- Participating in assigned projects towards desired business outcomes.
- Promoting a work environment that challenges the status quo, leads and adapts to change, as well as creates significant positive changes in the workplace.
- Creating a trusting, collaborative, and ethical work environment that positively contributes to employee engagement and retention.
- 2 to 3 years’ experience working in Medical Devices field, preferable complaint management and vigilance
- Fluent English (both spoken and written) is essential,
- Formal education in a technical, engineering or medical field is preferable
- Experience of GLP would be an advantage
- Experience of a technical environment, the medical device / healthcare industry would be a plus
REQUIRED KNOWLEDGE, SKILLS, ABILITIES
- Strong decision-making skills
- Ability to handle multiple priorities/ sudden changes in priorities
- Strongly quality orientated
- Team player with an ability to work across functions and cultures
- Ability to learn and adapt
- Strong technical writing skills
- Good working knowledge of Excel
- IT-literate (MS Office applications, Internet browsing, e-mail)
- Results oriented - Able to work well in a fast-paced environment
- Knowledge of applicable quality, FDA (Food & Drug Administration); Medical Device Directives & ISO (International Organization for Standardization) requirements
- Knowledge of human anatomy and medical terminology
- Able to work flexible hours as needed to support urgent business needs
If you feel attracted by this challenge and want to be part of a successful and growing organization, then please send us your online application (CV, Motivation Letter, Working References etc.) by clicking here.
Ethicon SarL (8786)