020 3198 1686

Quality Systems & Operations Manager in Genève, Switzerland

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Location
Genève, Switzerland
Salary
Negotiable
Job type
Permanent
Category
Operations, Clinical/Medical, Management/Exec
Job Id
ACQSOP/SWI
Posted on
29 Mar 2017
View all Jobs from RBW Consulting

About the Role:

One of the most interesting and innovative Medical Device groups

I am exclusively assisting one of the most interesting and innovative Medical Device groups globally as they strengthen their EMEA Quality team with their newest member of staff. In this newly created function, the successful applicant will be appointed the ‘Quality Systems & Operations Manager’ to be based either within their offices in Switzerland or Germany. This role will play a vital part in the management of a number of activities associate in RA and Quality Compliance while interfacing with a number of critical teams both internally and externally.

Key responsibilities

Key Leader and POC for all QA Operations activities

Work on a cross functional basis with a number of teams which includes the QA operations team, Sales teams, RA and Service teams

Support both the US and EMEA organisation the improve key processes for 3rd parties, Suppliers and other key initiatives with the designated region

Key representative for other aspects which include auditing, contract review and strategy design/implementation to align areas linked to RAQA

Assess the Regulatory landscape continuously and react to any developments affecting the distributor market

Key POC for notified bodies and healthcare authorities to ensure Compliance efforts are achieved

Support Senior RA manager with Compliance efforts to achieve the same goal

Support internal teams for RA guidance for new and existing product lines

Provide key support both internally and externally when needed

Monitor approval rates for distributor markets

Develop and implement RA QA Roadmap in Compliance for key areas related to Manufacturing, distribution, suppliers

Key Skills needed

Further education required in the field of Engineering, Life-Sciences or a related area applicable for the MD industry

At least 8 years exposure in QA for Medical Devices

Demonstrated exposure in areas related to Manufacturing, change control

Thorough understanding of RA requirements in the Medical Device industry

Fluency in English and German

Can work office based in the French area of Switzerland or from Germany

Can travel 25% of the time

Excellent understanding of the MD Regulation landscape

Demonstrated experience dealing with 3rd parties and distributors

Thorough, analytical and problem solver

Excellent organisations skills

Salary: On application

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