Quality Assurance Lead

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 Quality Assurance Lead is responsible for providing quality oversight of the Enterprise Solutions customer projects during manufacturing and/or engineering process in accordance with documented procedures and practices. This is a key quality role overseeing the development, implementation and continuous improvement of established Quality Assurance fundamental practices that are utilized in the Cytiva Enterprise solutions business.

This position reports to the Director, QA - Enterprise, Automation, Digital & Learning Solutions and is part of the Quality Assurance team located in Marlborough, MA and will be an on-site role.

What you’ll do

• Project QA lead independently overseeing the entire project lifecycle from kick-off, design development, execution, functional/FAT releasing testing through commissioning and qualification activities. Ensures quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility.
•  Responsible for the review and approval of Engineering design documents and executed protocols in a timely manner.
• QA lead supporting deviations and concessions during manufacturing. Perform and document investigations into manufacturing related process and product defects and responsible for coordinating field actions related to manufacturing issues.
• Initiates and owns nonconformance reports and CAPAs to mitigate manufacturing and QMS issues and utilizes risk management tools and aids for use by the organization in accordance with documented procedures, including but not limited to PFMEA, DFMEA, Fault Tree Analysis, Failure Mode Analysis, etc. and develops process mitigation plans and strategies that are designed to mitigate the risks identified through the Risk Management process.
•  Monitors quality and process issues during project execution and ensures appropriate corrective actions have been implemented and monitors project issues for trends to ensure continuous improvement.

Who you are

• Bachelor Degree or a minimum of 5 years work experience. Minimum of 5 years experience in a regulated industry is preferred
• Ability to communicate effectively in English (both written and oral).
• Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications. Desired Characteristics:
• Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820, ISO 13485 and ISO 9001:2015
• Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes

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

• Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production &process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc.
• Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance
• Demonstrated understanding of product developmen