- 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
- 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)
- 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
-
Danaher Corporation Tewksbury, United StatesBe 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 vaccin ...
-
Cytiva Tewksbury, United StatesBe part of something altogether life-changing 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 vacci ...
-
Danaher Tewksbury, United States Full timeBe 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 vaccin ...
-
Danaher Corporation Westborough, United States Paid WorkBe part of something altogether life-changing · 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 va ...
-
Danaher Corporation Westborough, United StatesBe part of something altogether life-changing 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 vacci ...
-
Danaher Corporation Westborough, United StatesBe part of something altogether life-changing · 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 vac ...
-
Cytiva Westborough, United StatesBe 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 vaccin ...
-
Cytiva Westborough, MA, United States Full timeWorking 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 therapie ...
-
Cytiva Westborough, MA, United States Full timeBe part of something altogether life-changing · 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 vac ...
-
Unarmed Security Officer
1 day ago
Jeeter Tyngsboro, United States**Unarmed Security Officer** · - DreamFields is one of the top 5 cannabis companies in the industry through our leading #1 pre-roll brand, Jeeter. The company is very passionate about producing world-class marketing, high quality, innovative products, delivering unprecedented cus ...
-
Security Systems Technician
3 days ago
Tiello Manchester, United StatesTiello has partnered with a highly reputable nationally renowned **Security Systems Integrator** located in **Manchester, NH. **The role will be a key player in a rapidly growing company. Ideal opportunity for someone looking for growth into management. · **Job Title: Lead Securi ...
-
Earned Value Principal Analyst
1 week ago
BAE Systems Nashua, United StatesYou don't see it, but it's there. Our employees work on the world's most advanced electronics -from saving emissions in the City of Lights to powering the Mars Rover to protecting the F-35 fighter jet. At Electronic Systems, you'll be among the brightest minds, working on the aer ...
-
Research Fellow
9 hours ago
Point32Health Boston, United StatesWho We Are · Point32Health is a leading health and wellbeing organization, delivering an ever-better personalized health care experience to everyone in our communities. At Point32Health, we are building on the quality, nonprofit heritage of our founding organizations, Tufts Healt ...
-
Security System Technician
1 week ago
Perfect Connections, Inc. Somerville, United StatesPerfect Connections, Inc. is a leading provider of security solutions, specializing in burglar and fire alarm systems and access control and surveillance systems for residential and commercial clients. With a commitment to excellence and innovation, we strive to deliver top-tier ...
-
Asbestos/demolition General Laborers
1 week ago
EnviroVantage Inc. Epping, United StatesAs the leading New England Environmental Specialty & Demolition Contractor with over 35 years of experience, EnviroVantage is recognized as the trusted authority for commercial, industrial, government and residential projects across New England and the Mid-Atlantic. The highly tr ...
-
Loss Prevention Supervisor Part Time
3 days ago
Omni Hotels & Resorts Boston, United States Part time**Location**: · The 1,054-room Omni Boston Hotel at the Seaport is the newest luxury hotel in the City of Boston, and the most significant hotel project in the city for the last forty years. The property features seven outlets for drinking and dining, a signature spa, fitness cen ...
-
Global Mdr Submission Manager
6 days ago
Olympus Corporation of the Americas Westborough, United States**Workplace Flexibility**:Field** · Are you looking for a company that cares about people's lives and health, including yours? Let's inspire healthier lives, together. · **Olympus, a leading medical technology company, has focused on making people's lives better for over 100 year ...
-
Director, Quality Systems
4 days ago
Lantheus Medical Imaging North Billerica, United StatesJob Description · Job Description · Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient ca ...
-
Director, Quality Systems
5 days ago
Lantheus North Billerica, United StatesLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. ...
-
Director, Quality Systems
1 week ago
Lantheus North Billerica, United StatesLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. ...
Senior Quality Assurance Product Surveillance Lead - Westborough, MA, United States - Cytiva
Description
Be part of something altogether life-changing
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. 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:
The essential requirements of the job include:
It would be a plus if you also possess previous experience in:
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
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 to request accommodation.
