- J&J Family of Companies (Danvers, MA)
- …and system monitoring **Qualifications:** + Bachelor's or Master's in Computer Science, Electrical/ Computer Engineering, or Embedded Software Engineering. ... for mechatronics products. + Experience with contract manufacturing, PCB design/ validation , and lab equipment. + Experience with in-circuit emulators, JTAG… more
- Bristol Myers Squibb (Devens, MA)
- …installations, configurations, administrative and support functions including system validation lifecycles and training. + Provide local administrative support ... **Qualifications** + BS degree in life sciences, engineering or computer field or equivalent experience. + Minimum of 2+...SOPs, cGMPs and other compliance requirements and regulatory guidelines ( FDA , EU) and the know how to work and… 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 the Quality ... requirements, design, development, integration, test protocols, test reports, verification, validation , and tooling. Ensure all documentation meets reliability standards… more
- Bristol Myers Squibb (Devens, MA)
- …+ Experience with managing a large budget. + Experience in Computer System Validation , Analytical Methods development/transfer, Quality Systems, Product ... regulatory experience in GxP environment. + Previous proven experience dealing with FDA and other major regulatory agencies. + Experience with digital innovation,… more
- Fresenius Medical Center (Waltham, MA)
- …the requirements of our internal Quality System, including specific requirements of GMPs, FDA QSR, relevant IEC standards, and ISO 9001. + Assist in Risk Analysis ... to relevant SOPs. **Education & Qualification:** + BS in Computer Science with a focus on software design and...Create and execute unit tests as part of software validation efforts + Strong knowledge of project lifecycles, software… 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 ... _Required:_ + Bachelor's degree in Electrical Engineering, Biomedical Engineering, or Computer Engineering. + 12+ years of experience in hardware/system engineering,… more
- Cardinal Health (Boston, MA)
- …(California Consumer Privacy Act), FDA (Food and Drug Administration)/GxP/CSV ( Computer System Validation ), DSCSA(Drug Supply Chain Security Act), as well ... as relevant governance frameworks to drive compliance to those regulatory requirements such as NIST, HITRUST, SOC 2, ISO, COBIT, ITIL, etc., while working with members of the Information Security and Risk Management team as well as stakeholders from Finance,… more
- Sumitomo Pharma (Boston, MA)
- …+ Assist in signal detection activities including data assembly, signal validation , and signal evaluation. + Perform literature monitoring (with vendor support) ... oncology, and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and… more
- Catalent Pharma Solutions (Chelsea, MA)
- …experience, preferably in cGMP biopharmaceutical, pharmaceutical, medical device, food, or other FDA regulated industry + Must have basic computer skills - ... consumer, and Catalent employee.** **The Role:** + Provide support for validation , calibration, and preventative maintenance of all Good Manufacturing Practices… more