Quality Assurance Engineer
Cytiva

Job Info

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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 one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.

To our new Chromatography Media Manufacturing site in Muskegon Michigan, we are looking for an experienced Quality Assurance professional. You will be part of our ongoing security of supply initiative to build a new chromatography media manufacturing site and product transfer from our manufacturing site in Uppsala Sweden.

What you'll do:

• Accountable for Quality Management System (QMS) document management, including but not limited to; leading the site document review board, authoring of local QMS work instructions, liaising with the Global QMS team on Global documentation updates and acting as the site administrator for the Cytiva electronic documentation management system (eDMS), and Veeva Quality Docs.
• Accountable for developing and maintaining the Site QMS training matrix, QMS trainings assignments and be the Subject Matter Expert (SME) in the eLearning system, Cytiva Learning (Cornerstone).
• Be the QA representative in global super user forums for the eDMS and eLearning systems, ensuring site needs are identified, system updates are communicated and implemented.
• Develop QMS process training materials and support classroom training efforts.
• Support of internal, customer and 3rd party audit programs.

Who you are:

• Bachelor's degree from an accredited University or College, preferably in a Science or Engineering discipline.
• A minimum 5 years working experience in Quality Assurance/Quality Engineering.
• Comprehensive understanding of ISO 9001 requirements. Understanding of GMP requirements, desired.
• Experience of working with QMS documents and training. MSOffice skills (Outlook, Word, Excel, PowerPoint)
• Auditing experience preferred.

It would be a plus if you also possess previous experience in:

• Strong analytical- and problem-solving skills.
• Strong communication skills (written and oral).
• Continuous Improvement, Risk analysis, FMEA experience.

Additional Requirements:

• Ability to be seated for 50% of the workday.
• Work with common computing technologies to access and manipulate company information.
• Lift up to 10 pounds occasionally, and up to 25 pounds infrequently
• Navigate through buildings on campus involving uneven surfaces and stairs in the manufacturing environment.

This job is also eligible for bonus/incentive pay.

We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.

Join our winning team today. Together, we'll 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.

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.

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.

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