Danaher Corporation Senior Quality Assurance Engineer in Eysins, 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 leader for new manufacturing site implementation and qualification
Plan, create and manage the overall Quality Planning strategy for new site implementation
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 iinvestigate the causes of non-conforming validation activities
Act as main contact with Notified body 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
Who you are
Typically requires a minimum of 10 years of related experience.
Bachelor's degree in Science, Engineering, Biotechnology, Quality Management.
Ability to implement strategies for risk management, deviation, CAPA project activities
Experience leading Equipment, System, Utilities and Process Validation and Qualification, Process Engineering and all associated Quality Assurance activities
Working to cGMP standards for FDA, MHRA and EU regulatory approval
Leading certification activities for new site ISO 9001 & ISO 13485
Computer experience required with working knowledge of Microsoft office programs
Good communication and inter-personal skills with ability to communicate clearly and concisely in both spoken and written form
Attention to detail and thoroughness in all aspects of the job, Cultural awareness and sensitivity, Ability to build rapport in a multinational environment
Team player who can get the best from others and build a rapport within a multidisciplinary team.
When you join us, you’ll also be joining Danaher’s global organization, where 68,000 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.
Danaher is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we’ll empower you to push the boundaries of what’s possible.
If you’ve ever wondered what’s within you, there’s no better time to find out.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .