Design Development QA Manager

Design Development QA Manager

Kelly Scientific Resources is a competent and experienced partner of the life science industry.
Our client, Roche Diagnostics International AG based in Rotkreuz, is a global player in Medical Device industry with innovative and market-leading products for the molecular and clinical Diagnostics. For an immediate support we are looking for a

Design Quality Assurance Manager

Main duties:

• 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

 
Experience:

• Workflow and IT projects process and tool competency for document management-workflow and IT projects process and tool competency for document management
• Audit experience in 13485 &21CFR820
• At least two years of experience as quality manager in the field of in vitro diagnostics or similar
• Proficient German and English
• SAP, HP-ALM is a benefit
• Expert knowledge in 14971, 13485, 62366, 62304, 21CFR, GDP is a huge plus
• Project Manager Training or several years of equivalent experience; PMI or PRINCE2 is an asset

 
For telephone inquiries, you can call Roman Freitag, at 044 225 41 08 or apply via E-Mail roman.freitag(at)kellyservices.ch.
 
Kelly Services (Schweiz) AG, Kelly Scientific Resources, Löwenstrasse 29, 8001 Zürich, 
Öffnungszeiten von Mo - Fr 8h00 – 12h00 / 13h30 – 18h00