Danaher Corporation Quality Specialist in Cardiff, 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.
What you’ll do
Participating in the operation of the Site Quality Management System, fully integrated into the Cytiva Quality Management System, including cross-functional and site-specific processes.
Ensuring site audit readiness and participating and supporting Quality System audits and inspections.
Providing input and oversight of Corrective Action / Preventive Action activities and Complaint Handling Programs, and in some cases, Quality Engineering.
Report on Quality System effectiveness and requirements to management team as required including preparing and participating in facility Quality Management Reviews.
Supporting site quality objectives, metrics, reporting and operating mechanisms.
Participating in selected global initiatives to share best practices and leverage quality synergies.
Supporting local R&D programs and quality issue resolution.
Who you are
Bachelor's degree in Engineering, Medical Device Technology or Scientific Field (or High School diploma/GED).
Minimum 3 - 4 years professional experience and understanding of product development, manufacturing, quality control and servicing in the medical equipment or pharmaceutical industry.
Experience with FDA, QSR, ISO, MDD and/or other international quality systems requirements.
Proven track record in performing external and internal audits with preferably a Professional certification as a Lead Auditor.
Ability to read, analyze, and interpret business plans, technical procedures and governmental regulations.
Effective report, business correspondence and procedure writing skills.
Good problem identification, multivariable analysis and creative resolution aptitude.
Proven process development and project management skills.
Strong computer skills.
Ability to communicate using English
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 (https://jobs.danaher.com/global/en/cytiva) , Instagram channel (https://www.instagram.com/cytiva/) and LinkedIn page (https://www.linkedin.com/company/cytiva/) !
Cytiva is global life sciences leader with over 7000 associates across 40 countries who are dedicated to our mission to advance and accelerate therapeutics. 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 solve complex 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 (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .