Head of Quality Medical Device JN -012021-18355 Client Description:
OpportunityOur client, one of the main leading medical devices producer, is looking for a Head of Quality.ResponsibilitiesReporting to AD, the Head of Qualitys primary responsibilities include:
to lead people, processes and activities in Quality Control, Assurance, Regulatory Affairs and Product Compliance;to challenge and continuously improve the existing Quality System with top management through process analysis, development and advancement;to ensure that all company activities are performed in compliance with local, state and federal regulations and laws governing business operations (mainly EU and US);to manage the Quality System for the holding company and respective affiliate companies located in Italy, EU and USA;to propose, develop and establish strategies for the creation and maintenance of the company Quality System and conformity to applicable standards (e.g.
ISO9001, ISO13485, ISO27001, IVD-R, 21CFR820,...);to ensure all pre-market and post-market requirements are fulfilled for the relevant business countries (mainly EU and US).Requirements (Qualification & Skills)Thorough knowledge and understanding of medical device regulations and standards, including but not limited to ISO9001, ISO13485, ISO27001, IVD-R, 21CFR820, Medical Device Directive;Exceptionally strong leadership and influencing skills, excellent verbal and written communication skills, including attention to detail;Strong questioning and listening skills and the ability to look beyond obvious answers in order to understand the impact on other areas is required;Experience building a high-performance team, managing performance of team members with varying levels of skill and experience, and mentoring high potential individuals to achieve greater impact on the organization;Significant experience of internal and external audit essential and having acted as lead auditor qualification would be an advantage;Management engineer background or equivalent;at least 10 years experience in IVD and/or Medical Devices;at least 5 years experience leading direct reports;experience in EU and US markets and regulations(preferred global);fluent business English.Location:
ComoRAL:
100.
#LI-DNIResponsibilities:
Head of Quality Medical Device JN -012021-18355 Client Description:
OpportunityOur client, one of the main leading medical devices producer, is looking for a Head of Quality.ResponsibilitiesReporting to AD, the Head of Qualitys primary responsibilitiesinclude:
- to lead people, processes and activities in...
Badenoch - Clark (UK):
Head Of Quality Medical Device Jn -012021-18355 Client Description:
OpportunityOur client, one of the main leading medical devices producer, is looking for a Head of Quality.ResponsibilitiesReporting to AD, the Head of Qualitys primary responsibilities include:
to lead people, processes and activities in Quality Control,...
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jobtomeClient Description:
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The...
Badenoch Clark (UK):
Head Of Quality Medical Device Badenoch - Clark (UK):
Head Of Quality Medical DevicejobtomeClient Description:
OpportunityOur client, one of the main leading medical devices producer, is looking for a Head of Quality.ResponsibilitiesReporting to AD, the Head of Qualitys primary responsibilities...
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Head of Quality Medical Device JN -012021-18355