- Hologic (Marlborough, MA)
- …If you're a detail-oriented problem solver with expertise in design verification, validation , and regulatory compliance, we encourage you to apply and make an ... impact on healthcare innovation. **Knowledge:** + Expertise in FDA Quality Systems Regulation (QSR), Design Control requirements, ISO 13485, ISO 14971 (Risk… more
- Sumitomo Pharma (Boston, MA)
- …in a regulated pharmaceutical environment. Ensure adherence to global regulations (GxP, FDA , EMA), manage IT risk, and oversee Business Continuity and Disaster ... + Ensure IT systems supporting GxP processes comply with FDA 21 CFR Part 11, EU Annex 11, and...other applicable regulations. + Maintain IT compliance documentation including validation protocols, SOPs, and audit trails. + Oversee periodic… more
- Hologic (Marlborough, MA)
- …a difference in healthcare innovation. **Knowledge:** + Strong understanding of FDA Quality System Regulations, including Design Control requirements, ISO 13485, EU ... principles, and compliance frameworks. + Preferred knowledge of test method validation , statistical methods, design of experiments (DOE), and industry standards… more
- J&J Family of Companies (Danvers, MA)
- …within Heart Recovery + Define and implement secure boot, firmware integrity validation , and anti-tamper mechanisms to protect Heart Recovery Device firmware against ... cryptographic protocols for data-at-rest and data-in-transit, ensuring compliance with FDA cybersecurity requirements, NIST 800-175, FIPS 140-3, and IEC 62443.… more
- Oracle (Boston, MA)
- …applying medical device standards (including IEC 62304, IEC 82304, and FDA guidance), define software interfaces, manage traceability across the system lifecycle, ... device software, ensuring vulnerability management and cybersecurity compliance with FDA and global regulatory expectations. + Apply the organization's Risk-Based… more
- Hologic (Marlborough, MA)
- …recommending actions. + Participate in internal and external audits, including FDA inspections and supplier audits. + Support monthly Quality Investigation Review ... required. + 2-5 years' experience in engineering, ideally within an FDA -regulated industry. + Experience in root cause analysis or product development/R&D… more
- Bristol Myers Squibb (Devens, MA)
- …the Cell Therapy Facility, including requirements gathering, design, implementation, validation , and ongoing support. + Oversee system integration with ... data flow and strong information security. + Ensure strict adherence to GxP, FDA , and other applicable regulatory standards in system implementation, validation ,… more
- Bristol Myers Squibb (Devens, MA)
- …team is responsible for quality oversight of engineering and validation lifecycle activities, including facility, equipment, and utility commissioning and ... qualification, computer systems validation , process validation , and technology transfer. The...a regulated industry with 1+ year experience. Experience in FDA /EMA regulations in biopharmaceuticals or cell therapy manufacturing is… more
- Insight Global (Westborough, MA)
- …process governance, KPI management and prioritization, tool administration and validation , validation automation planning, change control, integration testing ... coordination, and design validation tracking. This role requires direct execution of tasks...communication skills. Experience with SaMD / medical device regulations ( FDA , ISO 13485, IEC 62304, IEC 82304-1). Familiarity with… more
- Takeda Pharmaceuticals (Lexington, MA)
- …+ Ensure global compliance with applicable medical device and software regulations (eg, FDA 21 CFR Part 820, ISO 13485, ISO 14971, MDR/IVDR, MDSAP). + Act ... of global regulations and guidances governing medical device, including FDA 21 CFR Part 820, ISO 13485, ISO 14971,...+ Strong background in software development life cycle, SaMD/SiMD validation , and quality oversight. + Ability to translate and… more