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Supplier Quality Lead Engineer

Location: Cardiff
Company: Danaher Corporation
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This role will have some flexibility to work from home, but the successful candidate will need to be able to commute the office 3 days a week
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
- The Supplier Quality Lead Engineer will collaborate with Engineering, Project Management, Field Service teams, and Sourcing team on all activity required to effectively manage supplier quality requirements & supplier development. Primary areas of focus will be supplier auditing, qualification, continuous improvement and supplier change request resolution.
- Improve Supplier Quality performance for assigned suppliers through Quality Plan implementation.
- Assure Corrective and Preventive Action plans are developed and executed at assigned suppliers in compliance with the CAPA process.
- Assure supplier compliance to Cytiva QMS and regulatory requirements through supplier monitoring process.
- Collaborate with Suppliers and internal Stakeholders to drive Quality improvements that minimize the Costs of Quality and support implementation of Supplier/Engineering changes, New Product Introductions and Transfers.
Who you are
- Demonstrated technical aptitude: strong background in interpretation of drawings/ specifications, and manufacturing process planning / evaluation
- Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy to ensure compliance to Cytiva, regulatory and industry requirements
- Direct experience in supplier technical development or supplier quality development
- Excellent communicator and collaborator who can influence at all levels of the organization, both regionally and globally
- Earned a Degree in an engineering or technical discipline or equivalent non-technical degree with experience in Manufacturing, Engineering or Quality Assurance.
- Demonstrated knowledge of Clean-room production and Sterility Assurance
- Effective problem solver, with the skills to lead Root Cause investigations / CAPA plans and influence others cross-functionally.
- Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies and in-depth understanding of site level products and related processes.
- Qualified Auditor, who can lead, acknowledge, develop, communicate & implement a strategy to ensure compliance to GMP or Medical Device requirements.
- Experience with Single-Use Technology and Biopharmaceutical Manufacturing/Bioprocessing
- Desire and ability to travel ~30% of the time
- Proactive, self-driven, results seeking and enthusiastic intensity
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.
When you join us, you'll also be joining Danaher's global organization, where 69,000 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.
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