ProvidenceRecruiter Since 2001
the smart solution for Providence jobs

Quality Control Manager, Device

Company: Vertex Pharmaceuticals
Location: Providence
Posted on: November 16, 2020

Job Description:

In June 2019, Vertex announced the establishment of a new research site in the Boston area where research, development, and clinical manufacturing for cell and genetic therapies will be primarily based. Cell and genetic therapies represent two rapidly emerging therapeutic modalities with the potential to treat-and even cure-several of the diseases Vertex is focused on, including sickle cell disease, Duchenne muscular dystrophy and type 1 diabetes. Further investment in a research site specifically designed to advance these programs will be key to Vertex's continued and sustained leadership in these exciting approaches. At Vertex Cell and Genetic Therapies (VCGT) our research teams will bring together the best biology, technologies and enhanced manufacturing capabilities to ensure we bring these cutting-edge transformative therapies to patients as quickly as possible.

Key Responsibilities:

* Manage and serve as a mentor for up to five analysts
* Serve as a subject matter expert for QC tests (execution and troubleshooting)
* Execute QC tests for fully and partially assembled devices for the STx-01 program
* Execute materials characterization of polymers and adhesives, including the device membrane
* Evaluate properties of new and existing raw materials that are currently or will be used in development. Evaluations would be based on collection of data from: FTIR, DSC, TGA, etc.
* Execute release and stability testing per RMS requirements for raw materials to be used in GMP manufacture
* Collaborate with the QC, PD and manufacturing teams at Providence to execute testing in a timely manner, train personnel on new techniques
* Maintain regular dialog with AD personnel, assist in transferring developed assays from AD to QC
* Maintain relationships with external Scientific partners

Required Qualifications:

* Bachelor's Degree with 7-10 years' experience in biomedical/biomechanical engineering; 2-3 year's experience working on Class I medical devices
* At least two year's experience managing device QC groups of at least three analysts
* strong all-around knowledge of QA, validation and QC device regulations (e.g. 21CFR Parts 807 and 820, ISO 13485, ICH Q5C, ICH Q6B, ICH Q2, etc)
* Knowledge of polymer science and biomaterials
* Critical thinking and independence, ability to troubleshoot, solve difficult problems, and develop process/assay improvements

Preferred Qualifications:

* Master's Degree with 5 years' experience in biomedical/biomechanical engineering; 2-3 year's experience working on Class I medical devices
* Experience with implantation systems and Class I medical devices. Solid knowledge of device regulatory requirements.
* Familiar with the use, calibration, qualification and maintenance of the following instruments: DSC, TGA, FTIR, Gurley Tester/Timer, Instron Tester, Durometer, Viscometer and Leak Tester

#LI-KW1

Keywords: Vertex Pharmaceuticals, Providence , Quality Control Manager, Device, Executive , Providence, Rhode Island

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Executive Jobs


Chief Operating Officer Real Estate
Description: If you have leadership and management skills and are interested in an enterprising opportunity that will allow you to put your stamp on an organization, this position is for you. br br We are the (more...)
Company: CREG - Boston
Location: Wakefield
Posted on: 11/28/2020

Infrastructure Engineering Product Manager
Description: Job DescriptionThe Product Manager role for Infrastructure Engineering at Bose will be responsible for driving the delivery of secure, standards-based network infrastructure solutions across the enterprise (more...)
Company: Bose
Location: Stow
Posted on: 11/28/2020

Urgent Care Director Permanent Job
Description: Urgent Care opening in Boston, Massachusetts. This and other physician jobs brought to you by DocCafe.com Boston suburbs- Director
Company: Priority Physicians, Inc.
Location: Boston
Posted on: 11/28/2020


Case Manager II
Description: More personalized patient care br br br More professional impact br br br br br br BE THE CONNECTION. br br br br br br In your role as case manager, br you can be the (more...)
Company: Encompass health
Location: Woburn
Posted on: 11/28/2020

Research Project Manager I - Pediatric Oncology, Solid Tumor
Description: Overview br br Located in Boston and the surrounding communities, Dana-Farber Cancer Institute brings together world renowned clinicians, innovative researchers and dedicated professionals, allies (more...)
Company: Dana-Farber Cancer Institute
Location: Boston
Posted on: 11/28/2020

IT Project and Program Manager
Description: Requirements 10 years of experience as a Project Program Manager. Experience working as a Program Manager. Experience in ScrumKanbanAgile Waterfall Methodologies. Experience working on multiple projects (more...)
Company: Resourcesoft, Inc.
Location: Boston
Posted on: 11/28/2020

Domino's General Manager in Training - Bedford - Earn btw $15 - $18 per hour FIRST YEAR (3056)
Description: ABOUT THE JOB You were born to be the boss. We know. You get up in the morning and you make sure everyone else in the house is doing what they need to do. Then you go to work and you make sure that everyone (more...)
Company: Domino's
Location: Bedford
Posted on: 11/28/2020

Senior Manager of Strategic Marketing
Description: Working Location: MASSACHUSETTS, SOUTHBOROUGH Are you looking for a company that cares about people's lives and health, including yours At Olympus, we help make people's lives healthier, safer and more (more...)
Company: Olympus
Location: Southborough
Posted on: 11/28/2020

Permanent Medical Director Physician in Boston, Massachusetts
Description: Medical Director physician employment in Massachusetts : Medical Director
Company: Enterprise Medical Recruiting
Location: Boston
Posted on: 11/28/2020

Assistant Clinical Research Manager
Description: Overview br br Located in Boston and the surrounding communities, Dana-Farber Cancer Institute brings together world renowned clinicians, innovative researchers and dedicated professionals, allies (more...)
Company: Dana-Farber Cancer Institute
Location: Boston
Posted on: 11/28/2020

Log In or Create An Account

Get the latest Rhode Island jobs by following @recnetRI on Twitter!

Providence RSS job feeds