- J&J Family of Companies (Boston, MA)
- …moral character while professionally representing the company. + Comply with all corporate compliance, FDA , medical device , quality standards and ethics. ... + Must not be debarred by FDA for work in any Medical Device business. + Ability to work in a fast-paced environment while managing multiple priorities.… more
- Takeda Pharmaceuticals (Lexington, MA)
- …degree with 15+ years of experience** + Minimum 5 years of combination product, medical device , or pharmaceutical industry experience + Experience with both ... control principles, while fostering collaboration across multidisciplinary teams to deliver device clinical outcomes that exceed quality benchmarks and… more
- Medtronic (Billerica, MA)
- …and writing in English. **Preferred Qualifications (Must Have!):** + Prior experience in the medical device or electronics industry. + Knowledge of ISO and ... Billerica site. This role is critical to ensuring the quality and precision of our products. The ideal candidate...up to 6% match + Comprehensive benefits plan, including medical , dental, vision, and more + Fully subsidized Bachelors… more
- Medtronic (Newton, MA)
- …hardware components. Experience with regulatory compliance and security protocols specific to medical software (eg, HIPAA, FDA regulations) is preferred but not ... user-friendly interfaces that enhance the usability and functionality of our advanced medical devices. The Senior Software Engineer will be a key player in… more
- Philips (Cambridge, MA)
- …have a minimum of 3+ years' experience of Quality Engineering experience within FDA regulated, medical device product environments, with a focus in ... The Quality Engineer-Products and Systems is a key member...working knowledge of Risk Management (ISO 14971) and global medical device product regulations, requirements and standards.… more
- Hologic (Marlborough, MA)
- …we want to hear from you! **Knowledge:** + In-depth understanding of FDA Quality System Regulations, ISO 13485, and Medical Device Directive. + Expertise ... focus on integrity and compliance. **Experience:** + Minimum 12+ years in the medical device industry. + Proven track record in quality system strategy, risk… more
- Fresenius Medical Center (Lawrence, MA)
- …**PURPOSE AND SCOPE** Act as a Quality Business Partner for Software as a Medical Device and Non- medical software device engineering teams to ensure ... of Agile methodology desired but not required. . Thorough understanding of FDA Quality System regulations in relation to software development and validation or… more
- Abbott (Burlington, MA)
- …FDA regulations and guidance, ISO 13485, ISO 14971, Software Standards (eg, 62304), EU Medical Device Regulations and MDSAP + Experience with medical ... their lives. We are seeking an experienced **_Staff Software Quality Engineer_** to ensure our medical devices...activities. + Comply with US Food and Drug Administration ( FDA ) regulations, EUMDR, and other regulatory requirements and Abbott… 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 ... such as ISO 13485, ISO 11135, ISO 11137, and FDA requirements. **Cross-Functional Collaboration:** + Work closely with sterility...or related discipline, with 5+ years of experience in Quality Assurance role for medical device… more
- Teleflex (Mansfield, MA)
- …* 0-2 years of Quality Assurance experience working in the medical device manufacturing environment (a combination of education and experience will ... in ensuring the manufacturing processes comply with regulatory and quality system standards, including FDA , ISO 13485,... quality and manufacturing related processes in a medical device environment, preferred. TRAVEL REQUIRED: 0… more