Design Quality Assurance Manager (m/f)

REFERENZNUMMER:

358332/11

IHRE AUFGABEN:

-Represent 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
-Ensure 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 and participate in the planning of design control deliverables and/or project team outputs
-Support design and milestones reviews during product development and product care activities

IHRE QUALIFIKATIONEN:

-Master's degree in an administrative, technical or scientific discipline, or a qualification of equal value for the allocated tasks
-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 and 21CFR820 is an asset
-Project manager training or profound equivalent experience, e.g. PMI or PRINCE2 or equivalent is an asset
-German proficiency and English proficiency

WEITERE QUALIFIKATIONEN:

Quality manager