Job Detail

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.

 

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 (MDV). The Vigilance COE aims to deliver an efficient, effective and compliant Health Authority reporting with EEA, Switzerland and Turkey in accordance with local regulations.

 We are looking for a highly committed:  
Customer Quality Manager based in Neuchâtel
(Permanent)  

The Customer Quality Manager MDV is primarily responsible for the oversight of complaint file review and Medical Device Reporting elements of the Customer Quality Process. This individual will supervise the Mentor and Cerenovus Medical Device Vigilance team. This individual will serve as a backup for the Senior Manager in the COE.

 

Further responsibilities and duties are

• 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.


• Be a strong leader providing guidance, coaching, and mentorship to staff.


• Show positive initiative and ability to deal with ambiguity; in team situations, coordinate issues with peers and positively address conflict situations.


• Perform all duties and responsibilities in accordance with any professional requirements as well as those found in applicable policies and procedures and the Credo.


• Facilitate discussion with Medical Affairs as required.


• Prepare appropriate and timely reports.


• Support development of next generation processes and procedures to provide customer valued feedback (clinicians, authorities) and maintain high level of compliance.


• Act as point of Vigilance contact within EMEA for appropriate BU(s).


• Establish effective connections with major Stakeholders, (Franchise CHU’s, PMS groups etc).


• Collaborates and interacts with other location teams, including teams representing Manufacturing, R&D, Product Management and Supplier Quality.


• Provide internal and external Audit Support where required as an SME and/or front room lead.


• Communication with Health Authority(ies) in written and/or verbal form.


• Ensure compliance with MDD, MDR and ISO regulations.

Qualifications

• Baccalaureate degree, with medical, technical or business focus or equivalent experience.


• 5-10 years progressive experience within a regulated medical device environment a 3-5 years in complaint handling.


• Project management knowledge.


• Supervisory experience.


• Leadership capabilities.


• Excellent Communication.


• Fluent English (written & verbal).


• Interpersonal skills.


• Investigative & analytical.


• Results oriented.


• Prioritization skills.


• Self-starter.


• Able to work in a fast-paced environment.


• Applicable quality requirements knowledge (MDD, MDR & ISO, HIPPA, FDA).


• Statistical Methods knowledge.


• Complaint Management E-Systems knowledge.


• Document Control, Change Control, and CAPA Knowledge.


• Able to analyze & prioritize hard and soft data.


• Able to rapidly shift priorities.


• Customer focus.


• Clinical knowledge.


• Complaint process knowledge.


• Process improvement/ PE skills.

If you want to be a change agent in a challenging environment and shape the future quality organization, please send us your online application (CV, Motivation Letter, Working References etc.).


Primary Location

Switzerland-Neuchâtel-Neuchâtel-


Organization

ETHICON Women's Health & Urology Sarl (8566)


Job Function

Quality Assurance


Requisition ID

1905726378W