- Integra LifeSciences (Braintree, MA)
- …and manage time to meet organizational goals and objectives. + Experience with External Regulatory Agency audits (ie, Notified Bodies and FDA ). + Knowledge of ... are challenging what's possible and making headway to help improve outcomes. The Quality Design and Reliability Assurance (DRA) Engineer II is responsible for the… more
- Integra LifeSciences (Boston, MA)
- …A minimum of 2-4 years' experience in a medical device, pharmaceuticals, Quality / Regulatory Compliance, or other cGMP regulated product preferred environment. + ... and Drug Administration regulations, ISO 13485, and other applicable regulatory agencies as they pertain to laboratory testing. +...Familiarity with application of FDA and/or ISO quality standards in a… more
- Fresenius Medical Center (Lawrence, MA)
- …Understanding of Agile methodology desired but not required. . Thorough understanding of FDA Quality System regulations in relation to software development and ... and working remotely. **PURPOSE AND SCOPE** Act as a Quality Business Partner for Software as a Medical Device...minimize risk to users and patients as well as regulatory and corporate SOP compliance. . Reviews and approves… more
- Curia (Hopkinton, MA)
- …long-term feedback gathered from observations and evaluations + Assist Site Quality Head, during inspections by regulatory authorities, including implementing ... MANAGER, QUALITY ASSURANCE in Hopkinton, MA Build your future...of 5 years of relevant work experience in an FDA -regulated pharmaceutical environment with at least 2 years in… more
- Abbott (Burlington, MA)
- … system improvement activities. + Comply with US Food and Drug Administration ( FDA ) regulations, EUMDR, and other regulatory requirements and Abbott policies, ... location in the Abbott Heart Failure Division Global Design Quality Department . This is an ONSITE position. In...equivalent combination of education and experience. + Knowledge of FDA regulations and guidance, ISO 13485, ISO 14971, Software… more
- Bristol Myers Squibb (Devens, MA)
- …Practices. + Comprehensive knowledge of SOPs, cGMPs and other compliance requirements and regulatory guidelines ( FDA , EU) and the know how to work and ... and application administration, local support and liaison for global laboratory and quality systems, and administrator for local laboratory and quality systems.… more
- Nanobiosym, Inc. (Cambridge, MA)
- …is responsible for the organization and the coordination of processes pertaining to regulatory compliance and quality systems to ensure regulatory ... including the creation and documentation of validation protocols that comply with FDA regulations. + Provide troubleshooting focus and direction for the team with… more
- Nitto Denko Corp. (Milford, MA)
- …CAPAs, Batch Records, and associated GMP documentation to ensure compliance with applicable regulatory standards ( FDA , EMA, ICH). This role serves as a Subject ... About this opportunity : The Senior Quality Systems Specialist, QA will be responsible for...with document lifecycle procedures. + Maintain compliance with applicable regulatory and company documentation standards. + Represent QA in… more
- Hologic (Marlborough, MA)
- …architecture diagrams. + Collaborate with cross-functional teams (Product Engineering, DevSecOps, Regulatory , Quality ) to integrate security into the product ... Hologic products, and manage these risks according to established quality procedures. + Participate in continuous improvement of our... FDA submissions. + Maintain current knowledge of FDA and other regulatory body's cybersecurity guidance… more
- Hologic (Marlborough, MA)
- …team! In this role, you'll execute activities to ensure compliance with regulatory standards and Quality Management System requirements, conduct technical ... of regulatory standards like ISO-13485, ISO-14971, ISO-9001, CFR 820, and FDA requirements. + Familiarity with Quality Management Systems (QMS) and… more