Senior Quality Assurance Product Surveillance Lead

4 weeks ago

Tewksbury, United States Danaher Full time

Be part of something altogether life-changingWorking 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 Senior Quality Assurance Product Surveillance Lead for Cytiva is responsible for customer satisfaction through triaging, investigating, and closing product quality complaints.This position is part of the Quality Assurance Product Surveillance team located in Westborough, MA and will be hybrid. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.In this role, you will have the opportunity to:
Represent Westborough Product Complaint Handling Units (CHUs) in Site Management meetings. Tasks include generation of monthly metrics and QMR data review and presentation. Manage the QA monthly report out, with trends and CAPA initiative details.
Lead a Complaint Handling Unit (CHU) supporting and executing the triage, investigation, and closure of product quality complaints. Tasks include coordinating and supporting investigations, running trend reports, performing statistical analysis of trends, tracking major issues and related corrective actions, assisting in final customer reports, and interfacing with customers in various forms of communications.
Trend failure modes and emerging issues across various Westborough product groups and provides analysis around failure mode signals, root cause investigations, and subsequent corrective actions
Write and review technical reports and investigation/CAPA memos which are communicated to customers
Develop process improvement strategies and support execution of site/team continuous improvement goals and projects

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 5 years relevant experience industry experience (e.g. GMP medical device, pharmaceutical) preferred
At least 3 years relevant experience dealing with post market surveillance activities (complaint triage, investigations, CAPA, etc.) required; 4-6 years preferred
Extensive experience with cGMP and/or ISO 13485 including documentation, audit, and post market surveillance preferred
Excellent verbal, written, and presentation skills with the ability to communicate business issues clearly in English (and where appropriate, be able to communicate in the local language verbally and in writing)

It would be a plus if you also possess previous experience in:
Core QMS concepts, QMS architecture, QMS improvement activities
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

At Cytiva we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Cytiva can provide.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 [email protected] to request accommodation.

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