- Hologic (Marlborough, MA)
- …to have you on our team! **Knowledge:** + Strong understanding of FDA Quality System Regulations, particularly Design Control requirements. + In-depth knowledge of ... Regulation, and ISO 14971 (Risk Management). + Familiarity with test method validation , root cause failure analysis, and statistical methods. + Knowledge of… more
- Medtronic (Newton, MA)
- …efforts for Cardiac Ablation Solutions products, ensuring compliance with regulatory standards such as FDA CFR, MDR, IEC 62304, and ISO 13485. + Serve as a member of ... requirements, design, development, integration, test protocols, test reports, verification, validation , and tooling. Ensure all documentation meets reliability standards… more
- J&J Family of Companies (Danvers, MA)
- …regulatory documentation. + Develop Test Methods and understand requirements for Validation . + Support and/or drive sustaining activities of existing product lines, ... of Medical Device Design Controls and Product Life cycle + Knowledge of FDA and EU MDR regulations + Ability to communicate ideas and information clearly,… more
- Bristol Myers Squibb (Devens, MA)
- …their work + Completes documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records. + Solves complex ... requirements. **Knowledge, Skills, Abilities:** + Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing. + Must… more
- Bristol Myers Squibb (Devens, MA)
- …their work + Completing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records. + Performing ... requirements. **Knowledge and Skills:** + Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred.… more
- Charles River Laboratories (Wilmington, MA)
- …+ Molecular Biology + Immunology + Biomarkers + Method Development and Validation + Non-GLP Discovery Bioanalysis **Job Qualifications** The following are minimum ... worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits that elevate your… more
- J&J Family of Companies (Danvers, MA)
- …Strong analytical skills in tolerance stack-up, DFM/DFMEA, FEA or bench-test-driven validation approaches. + Demonstrated experience with root cause analysis tools ... medical technologies. + Familiarity with medical device regulations and design controls (eg, FDA , ISO 13485) and risk management per ISO 14971. + Test method… more
- J&J Family of Companies (Danvers, MA)
- …meet business objectives. + Implement robust processes for hardware verification, validation , and lifecycle management. + Partner with advanced technology teams to ... electronics, electromechanical integration, and embedded platforms. + Strong understanding of FDA design control, ISO 13485, and risk management practices. +… more
- AbbVie (Worcester, MA)
- …defend, persuade Corporate/Plant practices with outside organizations. Routinely meet with regulators ( FDA & EU) and customers to ensure no interruption in business ... API, finished goods, continuous improvement initiatives, QA training, laboratory equipment validation and stability depending on area of responsibility. + Applies… more
- ThermoFisher Scientific (Plainville, MA)
- …QC and analytical method transfer activities. Responsibilities include qualification, validation , and transfer of molecular and bioanalytical assays (including qPCR ... activities is required. + Experience with regulatory inspections from the FDA , EMA, Health Canada, or other regulatory authorities required. **Knowledge, Skills,… more