Danaher Corporation QA Leader in Cambridge, United Kingdom
Help us improve access to life-changing therapies that can transform human health
We are Cytiva, a global provider of technologies and services that advance and accelerate the development and manufacture of therapeutics. Formerly part of GE Healthcare, we have a rich heritage tracing back hundreds of years, and a fresh beginning since 2020.
Our customers undertake life-saving activities. These range from fundamental biological research to developing innovative vaccines, biologic drugs, and novel cell and gene therapies. Our job is to supply the tools and services - the pots, pans, soups and sauces - they need to work better, faster and safer, leading to better patient outcomes.
We are looking for a Quality Assurance Leader to work with our expert Quality Assurance Team of 300 employees across the world. Do you have a passion for ensuring quality and regulatory compliance and ensuring customer satisfaction? Then we would love to hear from you!
What you’ll do
Lead the implementation and maintenance of quality management systems (QMS) in alignment with corporate standards. Support ongoing quality system improvement programs and initiatives.
Drive improvement in customer experience – complaint reduction, supply reliability, field actions, audit performance, etc.
Coordinate the investigation and closure of deviations with specific emphasis on comprehensive root cause analysis. Ensure appropriate Corrective and Preventive Actions (CAPA) are initiated, implemented and monitored.
Develop and implement standardised metrics that guide actions and promote continuous improvement.
Review and approve documents such as SOPs, validation protocols and reports, deviation/CAPA plans, and change controls to ensure compliance.
Participate and/or lead internal and external audits.
Function as the Quality department liaison to other departments including but not limited to Quality Control, Manufacturing Operations, New Product Development, Regulatory and Supplier quality.
Who you are
Typically requires a minimum of 5 years of related experience working medical device industry.
Bachelor's degree in Science, Engineering, Biotechnology, Quality Management or Cell Therapy (preferred)
Has wide-ranging experience in core QMS management to ISO 13485
Expertise in handling or leading compliant processing and improvement initiatives
Knowledge of regulations pertaining to PMS, PMCF and CERs particularly in relation to the EU (MDD & MDR regulations) would be advantageous
Computer experience required with solid understanding of Microsoft office programs
Knowledge of medical device quality standards/practices or similar regulated industry
Good communication and interpersonal skills with ability to communicate clearly and concisely in both spoken and written form
Who we are
Whatever your role, we bring purpose and challenge into our everyday work. If you are driven to make the world a better place thanks to science and medicine, you’ll feel right at home here. If you’re flexible, curious and relentless, you’ll belong. If you are excited about a global culture, this can be the place to further your career.
Want to know more? Experience life at Cytiva on our Careers website, Instagram channel and LinkedIn page!
Cytiva is a 3.5 billion USD global life sciences leader with over 7000 associates across 40 countries who are dedicated to our mission to help us improve access to life-changing therapies that transform human health. As a trusted partner to customers that range in scale and scope, Cytiva brings efficiencies to research and manufacturing workflows, ensuring the development, manufacture and delivery of transformative medicines to patients.
Cytiva is part of the Danaher family of companies, a global science and technology innovator committed to helping customers tackle sophisticated challenges and improving quality of life around the world.
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.