Description
In this role, you will have the opportunity to:
+ Assure compliance with FDA Quality System Regulations (QSR), Good Manufacturing Practices (GMP), and ISO regulatory requirements.
+ Work directly and in coordination with cross-functional team members to tackle problems and implement lean manufacturing improvement ideas.
+ Identify and recommend quality improvements including but not limited to production methods, equipment performance, product quality and efficiencies.
+ Approve design changes/assessment of manufacturability for new processes, and management of resources (both monetary and labor related)
+ Train new team members on equipment operations and work procedures as needed.
+ Complete appropriate paperwork, maintain accurate records of production and report status of work.
+ Maintain organization and strategic training plan for the work area.
The essential requirements of the job include:
+ High School degree with 8+ years’ experience, or bachelor’s degree with 5+ years’ experience, or master’s degree with 3+ years’ experience.
+ Experience in a regulated industry preferred (e.g., FDA, ISO).
+ Proficiency with Microsoft applications, including Word, PowerPoint, and Excel and the basic Windows operating system.
It would be a plus if you also possess previous experience in:
+ Medical device manufacturing
+ Lean Manufacturing
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At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. 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.
The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.
