- Gilead Sciences, Inc. (La Verne, CA)
- …provides comprehensive support of these combination products. **Roles/Responsibilities:** + Monitor medical device standards for quality management system ... + Participate in external industry committees and ensure compliance with applicable medical device and combination product regulations + Participate in the… more
- Edwards Lifesciences (Sacramento, CA)
- …in a related field * Eight years of previous related experience in a Medical Device Industry, Quality System, hospital/clinical environment (eg cardiac care ... understanding of FDA's Quality System Regulation * Working knowledge of Medical Device regulations, such as FDA 21 CFR 820, ISO 13485; MDD; CMDR; MDD… more
- West Pharmaceutical Services (Walker, MI)
- …the development and execution of Quality Management System Compliance to Medical Device and Pharmaceutical regulations for Combination products and Drug ... or industrial engineering **Work Experience** + Minimum 10+ years in medical device /pharmaceutical manufacturing, quality assurance, regulatory affairs,… more
- AbbVie (Pleasanton, CA)
- …have 1 year of quality engineering work experience in FDA regulated medical device manufacturing environment(s). If experience required, must have 1 year of ... (QSR), ISO 13485, ISO 14971, MDR, & MDSAP; + performing all tasks according to medical device development life cycles, manufacturing processes & GMP; & + working… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …and other international requirements and submissions. + Knowledge of product development and medical device quality system regulations. + Experience with ... ensure US, EU, and other global regulatory requirements are met. + Evaluates medical device regulations and leads development of global regulatory strategies to… more
- Integra LifeSciences (Princeton, NJ)
- …mindset, a willingness to learn about bacterial endotoxin testing programs, an understanding of medical device quality systems, and a commitment to ensuring ... Engineer II with a focus on bacterial endotoxin testing programs in the medical device industry. The successful candidate will be responsible for partnering… more
- Olympus Corporation of the Americas (Brooklyn Park, MN)
- …degree (Supply Chain Management, Engineering, Finance or equivalent) + Supply Chain and/or Medical Device quality certifications or training is desired. + ... years of experience in New Product Development support, Vendor negotiations, Purchasing and/or Quality functions, preferably in medical device or other… more
- Integra LifeSciences (Boston, MA)
- …experience is required. + A minimum of 2-4 years' experience in a medical device , pharmaceuticals, Quality /Regulatory Compliance, or other cGMP regulated ... outcomes and set new standards of care. **ESSENTIAL DUTIES AND RESPONSIBILITIES:** The Quality Control Technician II will be responsible for performing quality … 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
- Jabil (West Chester, PA)
- …diverse communities around the globe. How will you make an impact? As a Quality Engineer, you will support key quality systems, ensure compliance with internal ... and procedures. + Support key business metrics by providing Quality Engineering expertise for manufacturing processes. + Conduct root... Engineering (eg, CQE) is a plus. Benefits + Medical , Dental, Prescription Drug, and Vision Insurance with HRA… more
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