-
Quality Assurance Test Manager
3 weeks ago
NavitsPartners Cambridge, United States**Position**: Quality Assurance Test Manager · **Duration**: 18-24 months · **Hours Per Week**: 37.5 · **Location**: Hybrid (Boston, MA) · **Position Summary**: · **Quality Assurance and Test Management**: · - Plan, execute, and lead testing efforts to ensure compliance with PROG ...
-
Quality Assurance Manager
3 days ago
RADcube Boston, United States**Quality Assurance Manager**: · **Type**:Contract | **Location**:Boston, Massachusetts · Primary Responsibilities · - Lead test strategy, balancing priorities such as test coverage, test quality, competing demands, and project schedule. · - Track, measure, and report on progress ...
-
Training and Quality Assurance Manager
2 days ago
Pine Street Inn Boston, United States**SCHEDULE**:40 hours, Monday - Friday, 8:00 a.m. - 4:30 p.m. (some evenings and weekends as needed) · **LOCATION**:Remote (with Travel) · **The Electronic Health Record Specialist is a non-essential position in the event of emergency or weather and will work 100% remote at this ...
-
Emerald Enterprises Cambridge, MA, United States FreelanceAre you looking to take the next step in your career? At Brunel, you have the opportunity to continuously develop yourself with renowned clients across industries. Take the decisive step in your career today and apply with us as a Project Manager for Automotive Quality and Produc ...
-
Vertex Pharmaceuticals Boston, United StatesJob Description · General Position Summary: · The Audit and Inspection Management Manager is responsible for the execution of audit and inspection management assigned activities, inclusive of internal and external processes, contributing to and executing audit plans, supporting i ...
-
Manager, Quality Assurance Operations
3 weeks ago
ElevateBio Waltham, United StatesElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicine ...
-
Assurance Manager
1 week ago
CohnReznick Boston, United StatesAs CohnReznick grows, so do our career opportunities. As one of the nation's top Professional Services and Business Advisory firms, we foster teams in Advisory, Assurance, and Tax services that value innovation and collaboration in everything they doWe currently have an exciting ...
-
Quality Assurance Manager
3 weeks ago
DV Die Cutting Inc. Danvers, United States**Overview**: · **Duties**: · - Develop and implement quality assurance policies and procedures · - Maintain ISO documentation · - Conduct regular quality audits to identify areas for improvement · - Oversee quality control processes, including QA/QC inspections · - Collaborate w ...
-
Quality Assurance Program Manager
1 week ago
INTEGRA TESTING SERVICES Needham, United StatesThe Quality Manager is responsible for leading the Quality Program for all CE Services locations and managing the onsite Microbiology Laboratory. · The Quality Manager assumes overall responsibility in ensuring that the division maintains operational and quality systems in a stat ...
-
Quality Assurance Manager
2 weeks ago
Adaptimmune Therapeutics Plc Cambridge, United StatesAdaptimmune is a fully integrated cell therapy company, designed and built from the ground up with four U.K.- and U.S.-based biotechnology hub locations. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologou ...
-
Quality Assurance Manager
3 weeks ago
Adaptimmune Cambridge, United StatesAdaptimmune is a fully integrated cell therapy company, designed and built from the ground up with four U.K.- and U.S.-based biotechnology hub locations. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologou ...
-
Quality Assurance Manager
3 weeks ago
Collabera Cambridge, United StatesJob DescriptionJob Description · Title:Quality Assurance Manager · Location: Cambridge, MA · Duration: 12+ months · Description: · 100% Onsite AMA · M-F (8am - 5:00 pm, flexible) · This role provides quality oversight with regards to the development and lifecycle managemen ...
-
Compliance Assurance Manager
4 days ago
Citizens Westwood, United States**Description** · The Compliance Assurance function is a part of the second line of defense and is responsible for providing independent assurance regarding the adequacy, effectiveness, and sustainability of regulatory risk management and control processes to ensure regulatory, c ...
-
Quality Assurance Manager
3 weeks ago
Adaptimmune Cambridge, United StatesJob Description · Job DescriptionAdaptimmune is a fully integrated cell therapy company, designed and built from the ground up with four U.K.- and U.S.-based biotechnology hub locations. Our comprehensive capabilities and teams include preclinical research, clinical development, ...
-
Quality Assurance Manager
1 week ago
The Brookline Center for Community Mental Health Boston, United StatesQUALITY ASSURANCE MANAGER · If you're excited about driving change and passionately believe that all people deserve access to quality behavioral health care, we have an amazing opportunity for you We're looking for people who want to be part of a fast-paced and entrepreneurial te ...
-
Assurance Senior Manager
1 week ago
Marcum Search Boston, United StatesMarcum LLP offers a great career with exceptional benefits. · There's a lot to think about when it comes to launching your accounting career. At Marcum, we offer you a world of opportunity, a highly competitive salary, exceptional benefits, flexible work options, and industry-le ...
-
Assurance Senior Manager
2 weeks ago
CohnReznick Boston, United StatesJob description · As CohnReznick grows, so do our career opportunities. As one of the nation's top Professional Services and Business Advisory firms, we foster teams in Advisory, Assurance, and Tax services that value innovation and collaboration in everything they do · We curr ...
-
Assurance Senior Manager
1 week ago
CohnReznick Boston, United StatesAs CohnReznick grows, so do our career opportunities. As one of the nation's top Professional Services and Business Advisory firms, we foster teams in Advisory, Assurance, and Tax services that value innovation and collaboration in everything they doWe currently have an exciting ...
-
Functional Quality Assurance Manager
1 week ago
Lockheed Martin Chelmsford, United States**Job ID**: 661173BR · **Date posted**: Feb. 15, 2024 · **Program**: Functional · **Description**:Lockheed Martin is seeking to hire a Functional Quality Assurance Manager for the Chelmsford, MA facility. Responsible for overseeing processes and leading direct-report team members ...
-
Quality Assurance Senior Manager
3 weeks ago
Ipsen Pharma Cambridge, United StatesTitle:Quality Assurance Senior ManagerCompany:Ipsen Bioscience, Inc.Job Description:Quality Assurance Senior ManagerIpsen is a global biopharmaceutical group dedicated to improving lives and health outcomes through innovative medicines in Oncology, Neuroscience and Rare Disease. ...
Quality Assurance Manager - Cambridge, United States - Collabera
Description
Job Description
Job DescriptionTitle: Quality Assurance Manager
Location: Cambridge, MA
Duration: 12+ months
Description:
100% Onsite AMA
M-F (8am - 5:00 pm, flexible)
This role provides quality oversight with regards to the development and lifecycle management of test and inspection methods and fulfillment of regulatory commitments. Potential scope of products with regards to test and inspection methods includes a wide range of devices, raw material components, and constituent parts, such as; needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems. The qualified candidate will both lead and/or support technical teams to ensure successful method development or remediation and/or fulfillment of regulatory commitments, provide quality oversight to one or more cross-functional teams to utilize technologies and methodologies that support short-cycle robust development, accelerated compliance efforts, and/or remediation/improvement opportunities. The Quality Assurance Manager will also provide Quality oversight of quality records such as Deviations, CAPAs, Change controls and review/approval of physical test methods documents.
Responsibilities:
Work cross-functionally and globally with individuals and project teams within Final Product Technologies Quality and the Final Product Technologies Engineering groups and their stakeholders in Marketing, Operations, and Development
Ensure compliance to design controls and fulfillment of user needs during test or inspection method development or design changes, including proper and compliant integration of different subsystems as required.
Provide quality oversight and guidance regarding the development of process control plans and implementation of process improvements/changes.
Work with cross-functional teams to develop, qualify, and transfer physical test or inspection methods.
Provide comprehensive quality guidance and advice to counterparts and stakeholders.
Provide Quality oversight of quality records such as Deviations, CAPAs, Change controls and review/approval of physical test methods documents.
Skills: BS or BE in Engineering and previous experience in the medical device and/or pharmaceutical industries
8 years current experience with engineering processes/procedures and quality tools. - Major contributions to or the leadership of projects from development through the 510k and PMA approval process.
Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification/validation, DOE/SPC process optimization & validation (IQ, OQ, PQ), P/DFMEA.
Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.
Experience in test or inspection method design and development - Small scale device assembly and/or benchtop testing experience.
Experience with Automated Test Equipment (ATE). – Experience with regard to Measurement Systems Analysis/GRR principles, including study design/execution/troubleshooting
Experience with Deviations, CAPAs, Change controls and document review/approval
Strong critical thinking, problem solving, risk assessment, and risk management skills.
Must be capable of working on multiple projects in a deadline driven environment.
Top 3 Must Have Skill Sets:
*Experience in Pharma/Biotech background and quality assurance (minimum of 5-10 years)
*Experienced with processes involved in test, inspection for a wide range of devices, raw material components, constituent parts (needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems.
*Experience with physical method validation, qualification, transfers; quality management systems
Day to Day Responsibilities:
• Work with a cross functional team to ensure compliance to design controls and fulfillment of user needs
• Work with cross-functional teams to develop, qualify, and transfer physical test or inspection methods
• Review and approve physical test method design documents, validation, qualification and transfer documents
• Review and approve quality records (deviations, CAPA/EVs, change controls)
• Lead problem solving and lean improvement projects
Employee Value Proposition:
Career growth, opportunity, networking, experience
Possible Extension: Yes
Company DescriptionCollabera is a Global Digital Solutions Company providing Software Engineering Solutions for the world's most tech-forward organizations in the areas of Engineering, Cloud and Data/AI. With its roots serving the engineering needs of the world's most recognized businesses in Technology, Financial Services, Telecom and Healthcare, Collabera today operates across 60 locations in 11 countries, serves 30% of the Fortune 500, and has exceeded the industry growth rate by 3-4x for several years.
