Job Information
Danaher Corporation Design Assurance Leader in Grens, Switzerland
Be part of something altogether life-changing!
Working at Cytiva in the Life Sciences industry means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.
At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40 countries, Cytiva is a place where every day is a learning opportunity – so you can grow your career and expand your skills in the long term.
Cytiva is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.
What you'll do
Act as QA Design Assurance leader for new product implementation, transfer of manufacturing and other QA related projects as needed. Ensure excellence and compliance in project execution through effective project management and inter-department collaboration
Provide quality support and coordinates activities for collaboration programs with third parties and new product introductions NPIs and transfer of manufacturing projects
Plan, create and manage the overall Quality Planning strategy for new product transfer and implementation and projects
Create detailed, comprehensive and well-structured change control strategy and records
Review requirements, specifications and technical design documents to provide timely and meaningful feedback
Prioritize, plan and coordinate validation and commissioning activities
Manage all related QA activities associated with manufacturing transfer to new site
Manage QA input to validation protocols, reports and investigate the causes of non-conforming validation activities
Act as SME for audit and related support for certification
Identify key KPIs for product quality, collect quality data and present to Senior Management Team
Write, review and approve all new site documentation ensuring compliance with QMS
Suggest solutions to identified site problems to ensure consistent project execution
Identify quality assurance process bottleneck and suggest actions for improvement
Act as a deputy for Total Quality Leader with the delegation to approve documentation and as approver at design reviews and other meetings as required
Who you are
Bachelor’s degree in engineering or health sciences field or other related degree.
Minimum 5 years’ experience in an ISO 13485, medical device or pharmaceutical industry in an Engineering, Quality or Regulatory or R&D related role
Experience in a regulated environment and knowledge of equipment intended for GMP use
Demonstrated understanding of product development lifecycles, design change, document change control, process verification and validation methodologies, manufacturing/production process control methodologies, and servicing in a medical device environment.
Basic understanding of materials, properties, manufacturing processes, and product assembly.
Ability to read and interpret professional journals, drawings and technical procedures.
Strong investigation and root cause analysis skills and an ability to write robust CAPA plans.
Good strong QA process knowledge with an emphasis on technical skills to ensure understanding of technical data and information.
Experience of device/instrument hardware and software and any experience in single use disposable kits is desirable
Strong communication and writing skills
Proficient with Microsoft tools; Word, Excel, Power Point, Project, Minitab, and Visio.
Excellent verbal, written, and presentation skills with the ability to communicate business issues clearly in English.
When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.If you’ve ever wondered what’s within you, there’s no better time to find out.