Senior Quality Engineer

Be part of something altogether life-changing!

Working at Cytiva 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.

Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics.

The Lead Quality Assurance Engineer for Cytiva is responsible for various aspects of the QMS, including non-conformances, CAPAs, complaints, field actions, and change control.

This position is part of the Quality Assurance team located in Marlborough, MA. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.

In this role, you will have the opportunity to:

• Act as a subject matter expert in one or more of the following Quality Management System elements: Change Management/Change Control process, Nonconformance and CAPA process, Complaint and Field Action process as well as the PLM system
• Establish and maintain site/business unit level processes and procedures and responsible for following the Global process and procedures effectively within our Quality System.
• Collaborate with stakeholders across several business functions providing excellent customer service while creating and routing complex changes in our Quality System
• Lead or support quality and compliance projects as requested, and perform other assigned duties, as needed.

The essential requirements of the job include:

• Bachelor’s degree required; additional training/education preferred through ASQ (or relevant society) and/or Master’s level program
• At least 8 years relevant experience industry experience (e.g. GMP medical device, pharmaceutical) required
• At least 5 years relevant QMS experience dealing with investigations, CAPA, change control.) required; 6-8 years preferred
• Extensive experience with cGMP and/or ISO 13485 including documentation, audit, nonconformance and CAPA
• Excellent verbal, written, and presentation skills with the ability to communicate business issues clearly in English

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

• Experience with supporting change control systems (ECR / ECO)
• Analyzing and processing data with various statistical tools, and drawing relevant conclusions
• Working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems

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.

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.

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.