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 ...

We are looking for a Regulatory Affairs Specialist II to be a core member of the Digital Health team at WHOOP. As the Regulatory Affairs & Quality Systems Specialist II, you will execute regulatory strategy and support QMS maintenance deliverables for WHOOP SAMDs in a dynamic and ...

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. · ...

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 ...

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 ...

Oversee all aspects of the Quality Management System (QMS) across the Americas. · ...

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 ...

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, · 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 ...

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 ...

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... · ...

+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 ...

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. · ...

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 located in Somerville MA helping companies equip their workforce with composable connected apps leading to higher quality work improved efficiency and end-to-end traceability across operations. · ...

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

This role is a progressive-minded quality professional who thrives in a fast-paced, high-growth environment. You don't just see quality as a set of checkboxes; you are a strategic thinker who seeks to understand overall company objectives to manage your workload effectively and d ...

The Quality · Manger is responsible for leading quality improvement · for an AST processing or lab facility.This is an opportunity to join a company that will invest in you for the long-term. STERIS wouldn't be where it is today without our incredible people, who take true prid ...

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 ...