Quality Systems - Boston, MA

We are looking for a Regulatory Affairs Specialist II to execute regulatory strategy and support QMS maintenance deliverables in a dynamic and agile environment. · Support and submit U.S. regulatory documentation including Q-submissions, De Novo requests, 510(k)s, product change ...

This position plays a key role in supporting daily manufacturing activities by resolving operational issues and driving high-quality investigations. · 6+ years experience in pharma/biotech manufacturing environments. · Proven background in investigations, RCA, QC analytics, and G ...

We're on a mission to unlock human performance and health span at WHOOP. · Support and submit U.S. regulatory documentation including Q-submissions. · Create detailed regulatory deliverables for global distribution of medical devices. · Prepare regulatory submissions for medical ...

WHOOP is looking for a Regulatory Affairs Specialist II to be a core member of the Digital Health team at WHOOP. · This role requires creative problem-solving and adaptability in an innovative and evolving space. · ...

Overses all aspects of quality management system qms across americas ensures qms design maintenance execution governance supports business objectives through proactive monitoring global regulatory requirements regional qms leading governance employee awareness knowledge applicati ...

ElevateBio 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 ...

The Quality Systems Associate will be responsible for assistance with the daily administration of the quality management system document/records management. · Assist with review of documents under revision, issuance of records, tracking of controlled documents, and management of ...

The evolution and spread of drug-resistant infection is the world's great health care challenge, · Partner with senior stakeholders to design and implement a robust ISO-13485 Quality Management System, · At least 10 years of hands-on experience developing and maintaining ISO-1348 ...

· At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. · Position Summary · The Quality Manager is responsible for leading quality improvement for an AST processing ...

We are seeking an experienced Senior Quality Systems & Compliance Specialist to support Quality Systems and Compliance activities within a regulated pharmaceutical environment. · ...

+The evolution and spread of drug-resistant infection is the world's great health care challenge, · with the number of deaths associated with AMR (antimicrobial resistant) infection predicted to exceed mortality · from cancer by 2050. · +Partner with senior stakeholders to design ...

We are looking for a Quality Systems Engineer to join our team in Somerville, MA. As a progressive-minded quality professional, you will thrive in a fast-paced, high-growth environment and have the opportunity to drive our digital transformation efforts. · ...

This role is to own and manage individual QMS processes and ensure their ongoing compliance and continuous improvement cross functionally.We are looking for a Quality Systems Engineer who can lead quality and validation-related discussions with incoming and existing customers. · ...

A System Quality Engineer ensures that products meet the highest quality standards. Responsible for investigating and resolving issues. · ...

A System Quality Engineer ensures that products meet the highest quality standards. Ensures products meet the organizations and customers quality and product integrity requirements. · Provide technical assistance and support to customers, suppliers, and employees in resolving iss ...

Overview: · Draper is an independent, nonprofit research and development company headquartered in Cambridge, MA. The 2,000+ employees of Draper tackle important national challenges with a promise of delivering successful and usable solutions. From military defense and space explo ...

Job Description · Quality Systems Specialist II · Key Areas Of Job Accountability · The Quality System Specialist II, under the direction of the QS&C management team, will be responsible to support and continuously improve the global DMS, LMS & QMS systems, and their operations, ...

Job Description · Quality Systems Specialist II · Key Areas Of Job Accountability · The Quality System Specialist II, under the direction of the QS&C management team, will be responsible to support and continuously improve the global DMS, LMS & QMS systems, and their operations, ...

We are seeking an experienced Senior Quality Systems & Compliance Specialist to support Quality Systems and Compliance activities within a regulated pharmaceutical environment. · ...

The Company · Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. · Assist with review of documents under revision... · ...