- Teleflex (Chelmsford, MA)
- Quality Engineer II (Manufacturing) **Date:** Aug 13, 2025 **Location:** Chelmsford, MA, US **Company:** Teleflex **Expected Travel** : Up to 10% **Requisition ID** ... driven by our purpose to improve the health and quality of people's lives. Through our vision to become...vendor audits if necessary. Support the Back Room during regulatory and notified body audits. * Production & Process… more
- Rhythm Pharmaceuticals (Boston, MA)
- …our Boston or Amsterdam office to play a key role in ensuring quality and regulation-based compliance during the manufacture and distribution of Rhythm clinical and ... Group. Their main activities include managing the day-to-day administration of quality processes and records, ensuring operational excellence in GxP compliance, and… more
- Tecomet (Woburn, MA)
- …the training initiatives and document control and records to ensure compliance to FDA , Global Regulatory bodies and ISO requirements. Training includes but is ... not limited to quality control, work measurement, manufacturing methods, and supervisory/management development. Manage the document system and records to ensure… more
- North Coast Seafoods (Boston, MA)
- …contact between the production staff and the Quality department for all Quality , Food Safety and Regulatory issues + Responsible for filling out assigned ... The Quality Control Technician is responsible for testing seafood...motions: bending, twisting, squatting and reaching + Exposure to FDA approved cleaning chemicals + Exposure to temperatures: <32… more
- Hologic (Marlborough, MA)
- …implement, and monitor a robust Internal Audit Program, ensuring compliance with FDA regulations, ISO standards, and other global regulatory requirements. If ... patient safety and innovation. **Knowledge** + Deep understanding of FDA Code of Federal Regulations (21 CFR 820), ISO...(eg, ISO 13485:2016, ISO 14971), MDSAP, and other global regulatory requirements. + Expertise in Quality Systems… more
- Dana-Farber Cancer Institute (Boston, MA)
- The Cell Processing Quality Control Specialist I trains and becomes competent at performing, interpreting and reporting for quality control assays required for ... cellular product evaluation. Responsible for the quality control (QC) of reagents, supplies, facility environmental testing,...the same manner as patient specimens. + Follow regulations ( FDA , CLIA, HIPAA, OSHA, state), standards (FACT, JC) and… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …complaint handling, customer turn- around and event reporting systems. Supports quality improvement, corrective and prevention action program. Works under general ... supervision. Reports to Supervisor and/or Quality Assurance Manager.Essential Functions + Review complaint investigations for...MS Office, including Excel and Word. + Knowledge of FDA QSR required + Knowledge of USA and international… more
- Sumitomo Pharma (Boston, MA)
- …and achieve goals effectively. + Regulatory Engagement: Interface with regulatory authorities, including the FDA , EMA, and other global agencies, ... teams. Regulatory Interactions: + Prepare and present clinical data to regulatory agencies ( FDA , EMA) during IND submissions, clinical study reports, and… more
- Sanofi Group (Cambridge, MA)
- …compliance with all corporate and industry policies and legal and regulatory requirements, for all medical affairs activities + Ensure promotional/non-promotional ... include major assets, sound medical advice that minimizes the risk of regulatory and legal action, competitively positions assigned products and is consistent with… more
- Catalent Pharma Solutions (Chelsea, MA)
- …various quality assurance checks during all manufacturing processes; Assess regulatory and quality risks in manufacturing activities and processes according ... to regulatory agency rules and guidelines; Conduct quality ...with protocol and implement validation procedures in accordance with Quality System Regulations (QSR), FDA and international… more