- J&J Family of Companies (Danvers, MA)
- …applications on real-time operating systems. + Good understanding of FDA 524B cybersecurity guidelines. + Comfortable with system-level troubleshooting using ... EE and software tools. + Knowledge of QNX would be a big plus. + Experience in the medical device industry is strongly preferred. + Working knowledge of cardiovascular physiology would be a big PLUS. + Willing to travel 5% of the time to meet with customers to… more
- Philips (Cambridge, MA)
- …Post Market Quality/Respiratory Care, with proven experience working within FDA regulated Complaint Handling/Vigilance Reporting medical device environments. + You ... have experience leading Post Market/Complaint Handling teams/projects, including training in complaint handling, ensuring timely/effective responses to customer issues, and fostering a culture of continuous improvement/excellence in customer relations within… more
- Teleflex (Chelmsford, MA)
- …the quality management system (QMS) in compliance with regulatory requirements (eg, FDA , ISO 13485). *Backup support for the training associate. *Collect, analyze ... and report quality metrics to drive continuous improvement *Ensure compliance with regulations, laws and guidelines *Perform additional duties as assigned This position requires direct contact with an implantable device. ☐ Yes ☒ No **Education / Experience… more
- Charles River Laboratories (Cambridge, MA)
- …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 ... quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.… more
- BioLife Plasma Services (Boston, MA)
- …QUALIFICATIONS:** + Experience working with SOPs, GDP, GMP, CLIA, and the FDA + Experience working in a highly regulated environment **We Offer Comprehensive ... Benefits from Day One** + Major medical, dental, and vision insurance and prescription coverage for eligible employees + A minimum of 15 vacation days and 10 company paid holidays + Tuition reimbursement + Retirement savings with a generous employer… more
- ConvaTec (Lexington, MA)
- …developing medical devices under quality systems compliant with ISO 13485 and FDA requirements + Strong interpersonal and leadership skills, with a track record ... of effective collaboration across both internal and external stakeholders. + Expertise in tissue culture, cell culture, biochemistry and molecular biology particularly where medical devices interact with users, experience in histology is desirable + Mammalian… more
- Charles River Laboratories (Cambridge, MA)
- …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 ... quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.… more
- Sanofi Group (Cambridge, MA)
- …a highly visible and priority launch asset for Sanofi Specialty Care. Since its FDA approval in 2023, ALTUVIIIO has been steadily gaining market share and represents ... tremendous opportunity ahead to positively impact the Hemophilia A community. This role will work in close partnership with key US functional partners including Thought Leader Liasons, Sales, Digital Marketing & Insights, as well as our Global Marketing teams.… more
- Medtronic (Newton, MA)
- …with regulatory compliance and security protocols specific to medical software (eg, HIPAA, FDA regulations) is preferred but not required. The ideal candidate is a ... problem-solver at heart, adept at diagnosing and resolving complex problems while optimizing for performance. With a passion for continuous learning and improvement, they stay ahead of the curve, leveraging the latest technologies and methodologies to drive… more
- Hologic (Marlborough, MA)
- …of regulatory standards like ISO-13485, ISO-14971, ISO-9001, CFR 820, and FDA requirements. + Familiarity with Quality Management Systems (QMS) and Production ... Part Approval Process (PPAP). + Knowledge of metrology, statistical tools (SPC, TQM), and risk management practices. + Proficiency in computer tools like Microsoft Office (Intermediate-Advanced) and Agile/Oracle (desirable). **Skills** + Exceptional… more