Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?At Cytiva, one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact.You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.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. Take your next step to an altogether life-changing career.Learn about the Danaher Business System which makes everything possible.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
Cytiva, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.The salary range for this role is $105.000-$130,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range. This range may be modified in the future.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 ...@danaher.com to request accommodation.