Quality Assurance Lead in Shrewsbury, Massachusetts
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.
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.
Monitors quality and process issues during project execution and ensures appropriate corrective actions have been implemented.
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.
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 ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance.
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.
Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology.
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.
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.
#J-18808-Ljbffr
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.
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.
Monitors quality and process issues during project execution and ensures appropriate corrective actions have been implemented.
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.
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 ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance.
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.
Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology.
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.
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.
#J-18808-Ljbffr
