- West Pharmaceutical Services (Scottsdale, AZ)
- …System (QMS) or Quality Assurance or Quality Engineering role(s) specifically within medical devices is essential ( medical device manufacturing preferred). ... 5 Why's, 6M's, 8D's, and DMAIC. + Regulatory Knowledge: In-depth understanding of Medical Device Regulatory Requirements and Standards, including 21 CFR Part… more
- BD (Becton, Dickinson and Company) (Sparks, MD)
- …Ensures supplier activities remain in compliance with domestic and international medical device standards, directives, and regulatory requirements Supports the ... 21 CFR 210-211, MDD/MDR, IVDD/IVDR, requirements and European/US GMPs related to medical device and pharmaceutical manufacture. + Experienced in project… more
- Philips (Plymouth, MN)
- …requirements to devise and deliver optimal design solutions for sophisticated medical device components, showcasing advanced technical expertise, working under ... fixtures, automation, and software, as applicable) to ensure scalability and compliance with medical device regulations (FDA QSR, ISO 13485). + Mentor junior… more
- Hologic (Londonderry, NH)
- …you an experienced quality professional with a passion for delivering excellence in the medical device industry? At Hologic, we are seeking a Quality Engineer 3 ... CAPAs. + Proficiency in analyzing quality system metrics and product quality data to identify trends and initiate corrective...years of experience as a Quality Professional in the medical device industry or equivalent combination of… more
- CSL Behring (King Of Prussia, PA)
- …sound, global, integrated regulatory vision / strategies for assigned product /s with a patient centric-focus, leveraging regional commercial insights and ... timely delivery of successful regulatory outcomes.** **Effectively partner with assigned product /s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other… more
- Terumo Neuro (Aliso Viejo, CA)
- …Teams, and Outlook. **Desired Qualifications** 1. Experience in a regulated industry, including medical device . 2. Working knowledge of planning tools such as ... plans including time dependency models for launch activities. + Develop a deep understanding of the assigned product... Develop a deep understanding of the assigned product and fully comprehend product lifecycle concepts… more
- Medtronic (Lafayette, CO)
- …will be tasked to provide quality engineering support in design and development of medical device products across the Acute Care and Monitoring [ACM] portfolio ... EU-MDR and the FDA Quality System Regulations. * Lead cross-functional teams to develop product risk management files (risk management plan, risk assessments,… more
- Amazon (Sunnyvale, CA)
- …posture of devices at scale * Provide technical security expertise and consultation to device product teams * Identify security risks and work with product ... responsible for empowering and enabling the organizations of Amazon Devices to develop and build secure products, including responding to public vulnerabilities and… more
- TP-Link North America, Inc. (Irvine, CA)
- …We are seeking a skilled Senior Embedded Software Engineer to design, develop , and optimize enterprise networking products such as routers, access points and ... reliability, and safety. You will be involved in every stage of the product life cycle, including development, manufacture, and maintenance and so on. Key… more
- Teradyne (San Jose, CA)
- …powering next-generation technologies through sophisticated solutions. Behind every electronic device you use, Teradyne's test technology ensures your device ... every time! Our portfolio of automation solutions help manufacturers to develop and deliver products quickly, efficiently and cost-effectively. Together, Teradyne… more