- Teleflex (Mansfield, MA)
- …nonconformances using (NC) process * First article inspections and product/process validation activities * Perform creation and inspection of product identification ... * Support document control activities (Agile updates, work package validation & storage) * Perform IV lab tests *...the medical device industry preferred * Experience with cGMP, FDA regulations, and ISO Quality Systems, strongly desired *… more
- Fresenius Medical Center (Lawrence, MA)
- …and Regulations such as 21CFR 820.30, IEC62304:2016 amd.1, IEC81001-5-1, as well as FDA and MDCG guidance. . Responsible for the planning and implementation of risk ... individuals with disabilities to perform the essential functions. . Extended computer -based work in an office environment. **EDUCATION** . Bachelor's Degree required… more
- J&J Family of Companies (Danvers, MA)
- …processing) for precise system operation. + Ensure compliance with IEC 62304, FDA design controls, and other applicable regulatory standards. + Develop and maintain ... in team meetings. **Qualifications:** + Bachelor's or Master's in Computer Science, Electrical/ Computer Engineering, or Embedded Software Engineering.… more
- Globus Medical, Inc. (Methuen, MA)
- …+ Support design transfer from R&D to production under ISO 13485 and FDA guidelines. + **Regulatory & Quality Compliance** + Ensure adherence to IEC 62304 ... cybersecurity standards. + Maintain documentation for design controls, verification, and validation activities. + **Innovation & Research** + Stay current with… more
- Catalent Pharma Solutions (Chelsea, MA)
- …manufacturing. The candidate provides support in automation engineering, design, and validation . The Automation Engineer II contributes to the design and ... Part11 assessments and GMP evaluations of control systems to ensure they meet FDA requirements + Prepares standard operating procedures for new and existing control… more
- GRAIL (Boston, MA)
- …power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's ... and other stakeholders to support regulatory strategy development, product validation , audits, promotional material review, on-market product support, and change… more
- Sumitomo Pharma (Boston, MA)
- …warehouse environment. + Ensure that all SAP solutions adhere to **GXP, FDA , and other regulatory requirements** applicable to the pharmaceutical industry, including ... validation and documentation standards. **Team Management & Governance** +...& Technical Skills** + Bachelor's or Master's degree in Computer Science, Information Technology, Engineering, or a related field.… more
- Fujifilm (Boston, MA)
- …technical aspects of Synapse product HL7 integration, from install, configure and validation phases through product go-live, for all Synapse MI products. HL7 IE's ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- Bristol Myers Squibb (Devens, MA)
- …of work + Completing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records. + Solving simple ... facility. **Knowledge, Skills, Abilities:** + Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred.… more
- Bristol Myers Squibb (Devens, MA)
- …their work. + Completes documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records. + Solves ... Authority requirements. **Knowledge and Skills:** + Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing. + Must… more