- AbbVie (North Chicago, IL)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Purpose: The Manager, Medical Device External Quality is part of ... and Product Quality Assurance group and reports to the Senior Manager, Medical Device External Quality . The role will be based out of Lake… more
- Organon & Co. (Jersey City, NJ)
- …and review of documentation to ensure compliance with applicable Medical Device Regulations and internal Organon requirements. Sr. Quality Engineer ( ... **This position will be the first contact support for external inspection support for Organon LLC and must work...cGMP and quality issues related to pure medical devices and the device constituent of… more
- Sanofi Group (Cambridge, MA)
- …will be responsible for the quality assurance efforts for our Software as Medical Device (SaMD) products, ensuring that they meet the highest standards of ... ensure the safety of all users and patients. **Supplier Quality :** + Manage external suppliers throughout the...sciences. + 4+ years' experience in medical device product development (Design Control) focused on quality… more
- Wolters Kluwer (Chicago, IL)
- …and promotional materials, 21 CFR 820, global medical device registration, technical writing, and external standards. **QUALIFICATIONS** **Education:** ... on-market medical devices including Software as a Medical Device (SaMD) within the Health Division...in existing processes and develop new processes. + Support external and internal audits; represent Quality Assurance… more
- Takeda Pharmaceuticals (Lexington, MA)
- …devices for drug delivery including combination products, solid understanding of polymeric medical device manufacturing processes via molding and assembly, and ... the creation of design control deliverables to comply with medical device and combination device ...External ** **Contacts:** + Collaborate with commercial Product teams, Quality , Mfg, Regulatory, R&D, Clinical, Legal + Work closely… more
- Sanofi Group (Morristown, NJ)
- …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 ... and 10+ years' work experience in combination product or medical device development, or MS/PhD in mechanical,...issues and challenges. + Strong knowledge of the US/EU external device -mediated drug delivery technology innovation eco-system.… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …development lifecycle of an off the shelf, or an internally designed platform medical device delivery system. + Defines detailed product requirements and ... equivalent combination of education and experience Previous experience in combination product/ medical device development or similar area is required. Experience… more
- West Pharmaceutical Services (Exton, PA)
- Senior Specialist, Regulatory Affairs - Medical Device Requisition ID: 69746 Date: Jun 11, 2025 Location: Exton, Pennsylvania, US Department: Regulatory Affairs ... regulatory requests. **Essential Duties and Responsibilities** + Develop and implement medical device regulatory strategies for West's administration and safety… more
- Aerotek (Irvine, CA)
- **Cleanroom Operator** + This position is responsible for the production of high- quality medical devices within a manufacturing cell. + Working under close ... test operations on pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related medical device assemblies. + The role requires spending 95% of… more
- PCI Pharma Services (Bedford, NH)
- …pioneer and shape the future of PCI. The **QA Operations Specialist I - Medical Device Floor Support** is responsible for providing QA support of Manufacturing ... and Visual Inspection activities for clinical and commercial medical device products in a GMP facility....* Cross functional staff, members of management, internal and external clients, members of the Quality organization… more
- Sanofi Group (Cambridge, MA)
- … development, manufacturing, quality , supply chain) and Global Business Units. Medical device technology is often exploring new territories that need "new" ... for device regulatory activities associated with Sanofi's combination product and medical device portfolio in the Specialty Care R&D and commercial product… more
- IQVIA (Baltimore, MD)
- …Sales Consultants_** to join our team of field employee's. **Associate Sales Consultant - Medical Device ** If you have ever wondered about the intricacies of ... surgical procedures or considered a career path in medical device sales, this is the role...presentable manner. Ensure client's services and offering meet highest quality standards + Know and follow all laws and… more
- Hologic (Marlborough, MA)
- …indications and environmental considerations for treatment **Experience:** + 2-5 years progressive quality experience in Medical Device or related Industry. ... Medical Device Reporting Specialist Marlborough, MA,...when required. + Assist in training employees within the Quality organization on medical devices developed and… more
- Sanofi Group (Morristown, NJ)
- …with key stakeholders including clinical, medical affairs, Industrial Affairs ( Device Development, manufacturing, quality , supply chain) and drug product ... team is a globally diverse team supporting the medical device , combination product, digital health and...standards and guidelines. The incumbent has a patient- and quality -focused mindset and drives a culture of continuous improvement… more
- Sanofi Group (Cambridge, MA)
- …with key stakeholders including clinical, medical affairs, Industrial Affairs ( Device Development, manufacturing, quality , supply chain) and drug product ... team is a globally diverse team supporting the medical device , combination product, digital health and...risks are highlighted + Work closely with internal and external partners to ensure regulatory risks are identified, communicated,… more
- Cognizant (San Francisco, CA)
- **IT Business Analyst - Medical Device Manufacturing** **Location** : Santa Clara **Job Description:** Cognizant is looking for an IT Business Analyst to serve ... their areas. **Core Responsibilities:** . Investigate, record, analyze and confirm medical device system requirements and business processes for manufacturing.… more
- HCA Healthcare (Nashville, TN)
- …want to join an organization that invests in you as a Director, Sourcing Medical Device Management? At HealthTrust, you come first. HCA Healthcare has committed ... difference. We are looking for a dedicated Director Sourcing Medical Device Management like you to be...new areas for contracting. Individual interprets complex internal or external business issues and takes a broad perspective in… more
- Lilly (Indianapolis, IN)
- …make life better for people around the world._ Organization Overview: The Indianapolis Device Assembly & Packaging (IDAP) quality assurance flow mentor provides ... , TS/MS, or engineering is preferred. + Experience in device assembly and packaging processes. + Good knowledge of...assembly and packaging processes. + Good knowledge of cGMP, external regulations and Lilly quality systems and… more
- Global Foundries (Essex Junction, VT)
- … architecture that meets the performance, cost, manufacturability, yield, reliability, and quality goals. The resulting device (s) should be the foundation of ... is seeking qualified candidates for the role of Power GaN Technology Development Device Leader. The Device Leader is expected to bring deep theoretical… more
- Amgen (Thousand Oaks, CA)
- …Medical Devices (21CFR820) and International Quality Management Systems for Medical Devices (ISO 13485). + Drug- Device and Biologic- Device Combination ... reviews. The candidate ensures that the required performance and quality targets are satisfied and helps identify and reduce...diploma / GED and 8 years of Engineering and/or Medical Device experience OR + Associate's degree… more