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Danaher Corporation Senior Quality Assurance Lead in Westborough, Massachusetts

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. Your health and wellbeing are important to us and together we will not compromise on safety in the workplace or the environment.

Cytiva is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.

What you’ll do

  • Assists in ensuring 100 percent quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility.

  • Leads, acknowledges, develops, communicates & implements a strategy to ensure compliance.

  • Responsible for the development, implementation, and continuous improvement of process effectiveness and efficiency at the site. Overall responsibility for CAPA program to ensure compliance with ISO 9001 and Cytiva procedures.

  • Ensures process compliance through the development of comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation.

  • Utilizes risk management tools in accordance with documented procedures. Supports risk mitigation activities through the Risk Management process.

Who you are

  • Bachelor's degree and minimum 8 years work experience in a Quality or Regulatory Assurance related field.

  • Minimum 6 years' experience in an ISO 9001, medical device or pharmaceutical industry in an Engineering, Quality or Regulatory related role.

  • Demonstrated understanding of root cause analysis, corrective and preventive action (CAPA), change control, verification and validation methodologies, manufacturing/production process control methodologies, risk management, and continuous improvement in a medical device environment.

  • Demonstrated knowledge of Quality Management System tools and ability to effectively communicate within all levels of the organization.

  • Experience with cGMP and governmental regulations related to drug manufacturing.

  • Ability to read and interpret professional journals and technical procedures.

  • Basic understanding of materials, properties, manufacturing processes, and product assembly.

When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.

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 (https://www.dol.gov/agencies/ofccp/posters) .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. If you’ve ever wondered what’s within you, there’s no better time to find out.

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