ProvidenceRecruiter Since 2001
the smart solution for Providence jobs

Quality Control Manager, Device

Company: Vertex Pharmaceuticals Inc (US)
Location: Providence
Posted on: September 17, 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 treatand even cureseveral 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 Vertexs 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:

* Bachelors Degree with 7-10 years experience in biomedical/biomechanical engineering; 2-3 year s experience working on Class I medical devices * At least two years 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:

* Masters Degree with 5 years experience in biomedical/biomechanical engineering; 2-3 years 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


Keywords: Vertex Pharmaceuticals Inc (US), 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

Other Executive Jobs

Executive Director, Credit Risk Review
Description: Executive Director, Credit Risk Review-----2002414--Description--The primary function of the Executive Director, Credit Risk Review is to assist the Board of Directors and senior leadership in the effective (more...)
Company: Santander Holdings USA Inc
Location: Manchester
Posted on: 09/20/2020

Manager Talent Acquisition - U.S. Business Unit
Description: By clicking the Apply button, I understand that my employment applic process with Takeda will commence and that I agree with Takeda s Privacy Notice, Privacy Policy and Terms of Use. Job Description Manager (more...)
Company: Takeda
Location: Lexington
Posted on: 09/20/2020

Director of Client Operations
Description: Welcome to the new standard of healthcare Premise Health is the world---s leading healthcare access provider. We deliver purpose-driven career experiences in a culture-centric work environment---ensuring (more...)
Company: Premise Health
Location: Lincoln
Posted on: 09/20/2020

Commercial Manager (Tele Presence/Remote Case Support) Job
Description: Date: Sep 11, 2020 Location: Marlborough, MA, US, 01752 Company: Boston Scientific Additional Locations: US-MN-Arden Hills US-MN-Maple Grove US-MN-Minneapolis Purpose and Passion - Comprehensive Benefits (more...)
Company: Boston Scientific
Location: Marlborough
Posted on: 09/20/2020

Restaurant Manager
Description: Job DescriptionGet Fired Up and Steer Your Career to great opportunities Your leadership ensures that our food, service, people and
Company: Longhorn Steakhouse
Location: Marlborough
Posted on: 09/20/2020

SE Section Manager - Mgr III Systems Engineering
Description: The Protected Communication Systems Department is involved all aspects of Systems Engineering across the program lifecycle of Protected Communication Systems programs within the Integrated Communications (more...)
Company: RTX
Location: Allston
Posted on: 09/20/2020

Director of Nursing
Description: Description Director of Nursing Campion Health Wellness, Inc. 319 Concord Road Weston, MA 02493 Campion Health Wellness, looking for a Director of Nursing to oversee our highly rated 70bed Skilled (more...)
Company: Campion Center
Location: Weston
Posted on: 09/20/2020

Workplace Experience (WX) Advisory Group Manager
Description: Country: br United States br br Cities: br Boston, Buffalo, Chicago, Cleveland, Columbus, Dallas, Denver, Detroit, Grand Rapids, Green Bay, Hartford, Houston, Indianapolis, Jersey City, Kansas (more...)
Company: Avanade
Location: Boston
Posted on: 09/20/2020

Future Opportunity: Manager - IAM Security Engineer
Description: Country: br United States br br Cities: br Boston, Hartford, Jersey City, New York City, Philadelphia, Pittsburgh, Washington DC br br Area of expertise: br Security br br Job Description (more...)
Company: Avanade
Location: Boston
Posted on: 09/20/2020

Family Office Tax Director
Description: Family Office Tax DirectorOur client, a private wealth management office that provides investment, accounting and tax and strategic wealth planning services to high net worth families is in search of (more...)
Company: Daley & Associates
Location: Boston
Posted on: 09/20/2020

Log In or Create An Account

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

Providence RSS job feeds