Dieses Jobangebot ist archiviert und steht nicht mehr zur Verfügung.
Vakante Jobangebote finden Sie unter Projekte.
Vakante Jobangebote finden Sie unter Projekte.
Design Quality Assurance Manager
Eingestellt von Randstad (Schweiz) AG
Gesuchte Skills: Design, Client
Projektbeschreibung
Randstad Professionals is currently looking for an experienced DESIGN QA MANAGER for a long term assignment in Central Switzerland.
Our client is a major name in the IVD industry. Currently looking for a German speaker to join a team of Design QA specialists
DESCRIPTION:
- Represents Design Quality Assurance in project teams to achieve sustainable compliance of projects
- Provides 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
- Educates the business in quality topics
- Participates in the planning of design control deliverables and/or project team outputs
- Supports design and milestones reviews during product development and product care activities
WORK/PROFESSIONAL EXPERIENCE
- At least two years of experience as quality manager in the field of IVD or similar and expert knowledge in 62304, 14971, 13485, 62366, 21CFR, GDP
- Audit experience in 13485 & 21CFR820 is an asset
EDUCATION
- Master's degree (from a university, or equivalent postgraduate studies) in an administrative, technical or scientific discipline, or a qualification of equal value for the allocated tasks
- Project manager training or several years of equivalent experience (1-5), (PMI or PRINCE2 is an asset)
Fluency in English is mandatory and HIGH LEVEL GERMAN IS EXPECTED - spoken and written.
If you are interested for this great role, don't hesitate to get in touch with me. I am looking forward to receiving your application in German or English
Our client is a major name in the IVD industry. Currently looking for a German speaker to join a team of Design QA specialists
DESCRIPTION:
- Represents Design Quality Assurance in project teams to achieve sustainable compliance of projects
- Provides 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
- Educates the business in quality topics
- Participates in the planning of design control deliverables and/or project team outputs
- Supports design and milestones reviews during product development and product care activities
WORK/PROFESSIONAL EXPERIENCE
- At least two years of experience as quality manager in the field of IVD or similar and expert knowledge in 62304, 14971, 13485, 62366, 21CFR, GDP
- Audit experience in 13485 & 21CFR820 is an asset
EDUCATION
- Master's degree (from a university, or equivalent postgraduate studies) in an administrative, technical or scientific discipline, or a qualification of equal value for the allocated tasks
- Project manager training or several years of equivalent experience (1-5), (PMI or PRINCE2 is an asset)
Fluency in English is mandatory and HIGH LEVEL GERMAN IS EXPECTED - spoken and written.
If you are interested for this great role, don't hesitate to get in touch with me. I am looking forward to receiving your application in German or English
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
IT Entwicklung, Medien/Design