- Hologic (Marlborough, MA)
- …+ In-depth understanding of FDA Quality System Regulations, ISO 13485, and Medical Device Directive. + Expertise in compliance issues and regulatory ... + Minimum 12+ years in the medical device industry. + Proven track record in quality system strategy, risk management, and regulatory compliance.… more
- Amgen (Cambridge, MA)
- …sites. This role requires a deep understanding of medical device design, manufacturing processes, and regulatory requirements. Key Responsibilities: + ... years of progressive experience as an engineer or scientist in relevant fields ( medical device development, manufacturing, etc.) + Proven track record of… more
- Teleflex (Chelmsford, MA)
- …such as metric reporting, document control, and audit participation. A strong background in quality assurance within the medical device industry, along with ... document retention policies, Good Documentation Practices and archiving / scanning Device History Records *Analyze and review quality system documents… more
- Integra LifeSciences (Braintree, MA)
- … mindset, a willingness to learn about sterilization and microbiology, an understanding of medical device quality systems, and a commitment to ensuring ... (Biomedical or Mechanical) or related discipline, with 5+ years of experience in Quality Assurance role for medical device or pharmaceutical manufacturing,… more
- Insight Global (Bedford, MA)
- … submissions, complaint systems, and reporting to authorities. - Solid knowledge of medical device regulations (eg, FDA QSR, EU MDR) and standards (eg, ... control and risk management activities for software and digital medical products (SaMD, SiMD) meet all required procedures, standards,...62304, IEC 62366, AAMI TIR57). - Deep understanding of quality / regulatory standards for SaMD and SiMD. -… more
- Takeda Pharmaceuticals (Lexington, MA)
- …(HFE) Lead - Associate Engineering Fellow (AEF) is responsible for Human Centered Design of Medical Devices and Combination Products. The HFE Lead - AEF will be ... knowledge of applicable guidance, regulations, standards, and industry best practices to medical device and combination product design and development process. +… more
- Integra LifeSciences (Braintree, MA)
- …(Biomedical or Mechanical) or related discipline with 5+ years of experience in Quality Assurance role for medical device or pharmaceutical manufacturing, ... activities. The role works closely with Product Development, Project Management, Regulatory , Marketing and Medical Affairs. **ESSENTIAL DUTIES AND… more
- J&J Family of Companies (Raynham, MA)
- …, Engineering or R&D with significant leadership experience in a regulated industry ( medical device , pharmaceuticals, or similar) + 5+ years of experience in ... learning, and innovation focused on customer-centric quality . + Ensure all quality activities comply with regulatory standards (eg, FDA, ISO) and internal… more
- Boston University (Boston, MA)
- …assurance monitoring and auditing on human research studies conducted at BMC and BU Medical Campus. The Human Research Quality Manager will evaluate and verify ... **HUMAN RESEARCH QUALITY MANAGER, School of Medicine, Clinical Research** **Job...MANAGER, School of Medicine, Clinical Research** **Category** Boston University Medical Campus --> Professional **Job Location** Boston, MA, United… more
- Hologic (Marlborough, MA)
- …Supplier Quality Engineering roles. + 5+ years of experience in medical device manufacturing or related industries. + Hands-on experience with manufacturing ... team! In this role, you'll execute activities to ensure compliance with regulatory standards and Quality Management System requirements, conduct technical… more