- Abbott (Maple Grove, MN)
- …and supporting CER related projects and processes. + Supports additional clinical, regulatory , quality and engineering related deliverable as assigned. + ... Regulatory Affairs, Library Services, Product Performance Group (PPG), Quality Engineering, Clinical Affairs, Clinical Science, Risk Management and Medical… more
- Abbott (Plymouth, MN)
- … requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... You'll Do** + Lead and implement complex development projects including quality improvement initiatives. + Sets strategies for cross-functional teams and drives… more
- Astrix Technology (Lino Lakes, MN)
- …selection, and process transfer activities-all in compliance with medical device quality and regulatory standards. Schedule: Monday-Friday, 7:30am-4:30pm Salary: ... CAD software and ERP/MRP systems for manufacturing planning. + In-depth understanding of regulatory requirements including ISO 13485, FDA , and GMP. + Strong… more
- Patterson Companies, Inc. (St. Paul, MN)
- …brand products. This role is critical in ensuring the procurement of high- quality products while maintaining cost-efficiency and meeting regulatory requirements. ... price, delivery, and service performance. + Collaborate with internal teams (marketing, quality assurance, regulatory affairs, supply chain and finance) to… more
- ManpowerGroup (Mendota Heights, MN)
- …for sourcing. This role is critical in ensuring the procurement of high- quality products while maintaining cost-efficiency and meeting regulatory requirements. ... price, delivery, and service performance. + Collaborate with internal teams (marketing, quality assurance, regulatory affairs, supply chain and finance) to… more
- Abbott (St. Paul, MN)
- …and supporting CER related projects and processes. + Supports additional clinical, regulatory , quality and engineering related deliverable as assigned. + ... and communications, risk reviews and other processes such as regulatory inquiries. + Ensures quality in all...(ISO13485, ISO14155, ISO14791, MEDDEV 2.7.1, MDR, and EU and FDA guidance documents) and applicable Abbott SOPs and DOPs.… more
- Abbott (Minnetonka, MN)
- … requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... and training modules (ie, guides and assessments) in conjunction with Training, Quality , and Engineering. + Reviews and recommends procedural changes pertaining to… more
- Philips (Plymouth, MN)
- …practices, cutting-edge tools, and innovative methodologies to continuously enhance software quality and regulatory compliance. + Will oversee the development, ... overseeing the review of test/performance data to ensure compliance with quality , safety, and regulatory standards, while identifying and addressing… more
- Medtronic (Mounds View, MN)
- …will join a world-class team of systems, mechanical, electrical, software, and quality engineers within Medtronic's Surgical Operating Unit (OU). The Surgical OU ... mitigation strategies in accordance with IEC 81001-5-1, ISO 14971, and FDA premarket cybersecurity guidance. + **Security Architecture & Design** - Collaborate… more
- Teleflex (Plymouth, MN)
- …medical technologies, Teleflex is driven by our purpose to improve the health and quality of people's lives. Through our vision to become the most trusted partner in ... for manufacturability, and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly… more