Senior QA Manager

Dauerhaft | Frankfurt am Main, HESSEN | 11 Monate | Frist: Dienstag, 16. Januar 2018, 00:00 Uhr
Diese Position ist abgelaufen. Nicht bewerben!

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Dauerhaft
; 100,000+

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Job 82 of 1000
Senior QA Manager

Company: ProClinical Ltd
Location: Frankfurt am Main
Reference: QA.GM.14772
Closing Date: 16 Jan 18
Type: Permanent
Salary (£): 100,000+
Benefits:


Job Summary:

ProClinical is seeking a Senior QA Manager for a global med-tech company and a leading supplier of innovative products in the fields of healthcare and information technology to be based in Frankfurt on a permanent basis. The Sr. Manager QA EMEA ensures that all activities performed in this region on behalf of our Client comply with the applicable quality-related regulations and that the business organization is supported in an effective and efficient manner for quality matters. ...


Requirements:

ProClinical is seeking a Senior QA Manager for a global med-tech company and a leading supplier of innovative products in the fields of healthcare and information technology to be based in Frankfurt on a permanent basis. The Sr. Manager QA EMEA ensures that all activities performed in this region on behalf of our Client comply with the applicable quality-related regulations and that the business organization is supported in an effective and efficient manner for quality matters.
Job Responsibilities:
* Management Representative for the site.
* Responsible for ongoing compliance of the Quality Management System and business practices with the applicable regulations by highlighting and implementing regulatory requirements, driving improvement initiatives, and where necessary escalating issues to Senior Management.
* Identifies areas for improvement for the global QMS and leads and/or participate regional or global Primary liaison for complaints and product quality for the EMEA direct countries and for distributors.
* Responsible for adequate and effective relationship management with TUV-Sued, Clients Corporate Marketing Supervisor General, and other regional or global teams of our Client, including operations, R&D, GHQ, as well as suppliers/distributors.
* Leads and/or participate in projects in a cross-functional, and cross-site setting as quality representative of the EMEA region.
* Responsible for adequate and effective management of external audits in the EMEA office.
* Oversees timely execution of all aspects of the complaint management process.
* Ensures timely vigilance reporting and closure.
* Serves as the primary contact for the direct sales organization and distributors in EMEA related to quality matters
* Supports the business in solving issues with customers and distributors that relate to quality.
* Ensures compliance of regional distributors and suppliers with the relevant QA/RA requirements of the business agreements.
Skills and Requirements:
* Bachelor degree in a technical discipline required
* 3 - 5 years of experience in management of ISO13485 compliant quality systems.
* Experience in complaint handling in a European context
* Leadership skills, people skills, project management skills, analytical skills. Possession of a good sense of supply chain and distribution is a plus. Ability to communicate technical medical device information.
* Proficient at process mapping, flowcharting, database systems, Excel spreadsheet, and Microsoft Office.
* Able to speak and write in English, and preferably Spanish. Able to work within a fluid and dynamic international environment.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Gilles Maricaux on +3224460153 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.


Contact Information:
Address:  ProClinical Ltd
Eldon House Eldon Street London
EC2M 7LS
England
Tel:  0800 988 4437
Fax:  +44 (0)207 834 9470
Website:  Visit Our Web Site

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