- Takeda Pharmaceuticals (Boston, MA)
- …communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, ... the Company-wide patient safety expert for assigned pharmaceutical / biological / drug- device combined products, accountable for the safety strategy and major safety… more
- Danaher Corporation (San Diego, CA)
- … devices , diagnostics, or life science instruments. + Strong working knowledge of medical device regulations and quality standards, including FDA (21 CFR ... of our products. You will collaborate closely with R&D, Quality , Regulatory , and Service & Support stakeholders...you also possess previous experience in: + Working with medical devices or other regulated businesses +… more
- Intertek (Boxborough, MA)
- Project Engineer - Medical Device Testing, Boxborough, MA Intertek, a Nationally Recognized Testing Lab (NRTL) and leading provider of quality and safety ... and companies is actively seeking a Project Engineer - Medical Device Testing to join our Electrical...independently performing testing and evaluation on a variety of medical devices and products to the requirements… more
- Abbott (Maple Grove, MN)
- …+ 3-5+ years of experience in clinical research, quality systems, or regulatory experience in medical device + Understanding of regulations, standards ... Heart Products combines understanding of scientific and research methodology, medical device regulations and guidelines, and product...and guidelines related to medical devices clinical studies, and … more
- Jabil (West Chester, PA)
- …make an impact? As a Quality Engineer, you will support key quality systems, ensure compliance with internal and regulatory standards, and provide day-to-day ... safety policies and procedures. + Support key business metrics by providing Quality Engineering expertise for manufacturing processes. + Conduct root cause analyses… more
- Merck (West Point, PA)
- … Development team and with external partners. + Understand and apply regulatory and compliance requirements relevant to device risk management activities, ... and skills:** + Minimum of 8 years of experience in pharmaceutical development, device development, device systems operations, quality management, or a… more
- Lilly (Indianapolis, IN)
- …(SME) Oversight** : + Demonstrate a strong ownership and stewardship for medical device design, manufacturing, labelling, and/or packaging processes you support ... by being flexible, proactive and involved. + Liaise with regulatory function to align on strategies for new products,...agendas. Understand key regulations and their impact to the medical device design transfer and post-launch surveillance… more
- Lilly (Indianapolis, IN)
- …development. **Additional Preferences and Information:** + Knowledge of cGMP requirements in medical device manufacturing, highly preferred. + Experience in ... and ensure alignment to business goals. Develop team goals for safety, quality , and process effectiveness and efficiency. + ** Regulatory Compliance:** Ensure… more
- AbbVie (North Chicago, IL)
- …preferred) + 3-5 years of experience (MS up to 2 years) ideally in the medical device , drug delivery or other regulated industry + Strong communication skills ... that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a...medicines. During our work we collaborate with early-stage CMC, Quality Assurance, Regulatory Affairs, Internal and External… more
- Actalent (Irvine, CA)
- …strategic M&A initiative with one of our engineering outsourcing clients in the medical device industry. We are seeking a detail-oriented Process Engineer with ... Requirements + Minimum 5 years of experience in validation engineering within the medical device industry required. + Prior technical expertise in process… more