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Design Quality Assurance Manager
Eingestellt von ITech Consult
Gesuchte Skills: Design, Support
Projektbeschreibung
DESIGN QUALITY ASSURANCE MANAGER
REFERENCE: 916946KS
LOCATION: Zürich und Region
ÜBER UNS: ITech Consult mit Hauptsitz in der Schweiz ist ISO 9001:2008 zertifiziert und hat Niederlassungen in Deutschland, Grossbritannien und Irland. ITech Consult besteht seit 1997 und wurde von Freiberuflern gegründet und wird von Freiberuflern geführt. Wir wissen, was es bedeutet, ständig im Einsatz zu stehen - und wir wissen auch, wie wichtig die professionelle Unterstützung bei der Projektsuche und -arbeit ist.
INDUSTRY: Medical
CAPACITY: 100%
START: 01/01/2018
DURATION: 30/06/2018 (vorerst)
INTRODUCTION: Our medical client in central Switzerland is looking for a Design Quality Assurance Manager
DUTIES:
- Represents Design Quality Assurance in project teams to achieve sustainable compliance of projects
- Provide design control quality support with a pro-active, business solution oriented approach, while collaboratively being involved in the generation
- Review and approval of design control documentation/deliverables during product development and product care activities
- Ensures that any design quality issues that may jeopardize the regulatory status of the projects and products in their work area are handled with the necessary priority and urgency
- Educate the business in quality topics
- Participation in the planning of design control deliverables and/or project team outputs
- Support design and milestones reviews during product development and product care activities
REQUIREMENTS:
- At least 2 years of experience as Quality Manager in the field of In Vitro Diagnostcs (IVD) or similar and/or expert knowledge in 62304, 14971, 13485, 62366, 21CFR, GDP
- Experienced in handling laboratory information systems (LAS)and order management as well as taking care of product development
- Support workflow projects either in laboratory automation or in IT Products
- Process and tool competency for document management
- ability to build influential and effective relationships with key stakeholders with special focus on proactive communication, enabling strategic quailty related solutions, input and support
- Develops and drives a work culture committed to business focus, compliance, and continuous improvement
- Education in project management, eg PMI or PRINCE2 is an asset
- SAP HP-ALM is an asset
- Audit experience in 13485 & 21CFR820 is an asset
REFERENCE: 916946KS
LOCATION: Zürich und Region
ÜBER UNS: ITech Consult mit Hauptsitz in der Schweiz ist ISO 9001:2008 zertifiziert und hat Niederlassungen in Deutschland, Grossbritannien und Irland. ITech Consult besteht seit 1997 und wurde von Freiberuflern gegründet und wird von Freiberuflern geführt. Wir wissen, was es bedeutet, ständig im Einsatz zu stehen - und wir wissen auch, wie wichtig die professionelle Unterstützung bei der Projektsuche und -arbeit ist.
INDUSTRY: Medical
CAPACITY: 100%
START: 01/01/2018
DURATION: 30/06/2018 (vorerst)
INTRODUCTION: Our medical client in central Switzerland is looking for a Design Quality Assurance Manager
DUTIES:
- Represents Design Quality Assurance in project teams to achieve sustainable compliance of projects
- Provide design control quality support with a pro-active, business solution oriented approach, while collaboratively being involved in the generation
- Review and approval of design control documentation/deliverables during product development and product care activities
- Ensures that any design quality issues that may jeopardize the regulatory status of the projects and products in their work area are handled with the necessary priority and urgency
- Educate the business in quality topics
- Participation in the planning of design control deliverables and/or project team outputs
- Support design and milestones reviews during product development and product care activities
REQUIREMENTS:
- At least 2 years of experience as Quality Manager in the field of In Vitro Diagnostcs (IVD) or similar and/or expert knowledge in 62304, 14971, 13485, 62366, 21CFR, GDP
- Experienced in handling laboratory information systems (LAS)and order management as well as taking care of product development
- Support workflow projects either in laboratory automation or in IT Products
- Process and tool competency for document management
- ability to build influential and effective relationships with key stakeholders with special focus on proactive communication, enabling strategic quailty related solutions, input and support
- Develops and drives a work culture committed to business focus, compliance, and continuous improvement
- Education in project management, eg PMI or PRINCE2 is an asset
- SAP HP-ALM is an asset
- Audit experience in 13485 & 21CFR820 is an asset
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Sonstiges