- Kelly Services (Marlborough, MA)
- …expertise and mentorship, without direct reports. **Preferred Qualifications:** + Experience in medical device or other regulated industries. + Familiarity with ... ** Design Controls Test Engineer ( NO C2C or...cross-functional collaboration. + Interface with external suppliers to ensure quality , compliance, and timely delivery of components and systems.… more
- Fresenius Medical Center (Waltham, MA)
- …regulatory compliance, quality engineering and auditing in the pharmaceutical or medical device sector or related industries + Several years of practical ... Fresenius Medical Care policies and procedures to drive continuous quality improvement. Support external quality management inspections at Fresenius … 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 ... part of software development team on new product development or on design changes to ensure product quality and minimize risk to users and patients as well as… more
- Nanobiosym, Inc. (Cambridge, MA)
- …engineering grade resins a must More than 10 years experience Must have medical device experience, disposables preferred. familiar with ISO13485 and 14971 Must ... be hands on and wear multiple "hats". -be ready to participate in quality systems, engineering, mfg, regulatory activities, etc. Individual would be a motivated,… more
- Philips (Cambridge, MA)
- …minimum of 3+ years' experience of Quality Engineering experience within FDA regulated, medical device product environments, with a focus in Design ... all stages of the product life cycle + Supports Quality Plan design for hardware and Software...working knowledge of Risk Management (ISO 14971) and global medical device product regulations, requirements and standards.… 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 ... Procedures (SOPs) for various quality and manufacturing related processes in a medical device environment, preferred. TRAVEL REQUIRED: 0 - 10 % \#LI-AD1… more
- Sanofi Group (Cambridge, MA)
- …vision control systems. + Knowledge of device and packaging regulations, quality systems, design fundamentals of combination products, design controls, ... and bring hope to patients and their families. The strategic vision of Sanofi's Global Medical Device and Packaging organization is to lead the industry in … more
- NTT America, Inc. (Boston, MA)
- …budget. The process is designed to identify and resolve issues early in the design and construction process to ensure quality , reliability, safety, and cost ... and operations teams to understand the project goals and schedule to ensure quality and commissioning activities occur at the appropriate times in the construction… 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 ... projects are in compliance with cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements. **DESIRED MINIMUM...or related discipline, with 5+ years of experience in Quality Assurance role for medical device… more
- Olympus Corporation of the Americas (Westborough, MA)
- …assessments, product security, cybersecurity, and equipment development oversight. Extensive knowledge of medical device design control requirements, system ... of design control elements to comply with medical device regulations. + Implement product ...appropriate specificity to enable high volume manufacturing with high quality . + Proficient in Microsoft Windows Office applications including… more