- 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 ... for medical devices and embedded systems. It is not an IT security, compliance , or GRC-focused position. The ideal candidate will have deep experience working with… more
- Medtronic (Fridley, MN)
- …ensuring systems meet both technical specifications and regulatory standards (eg, FDA , 21 CFR Part 11). You'll work closely with cross-functional engineering, ... quality , and manufacturing teams to standardize equipment control systems,...in reviewing vendor equipment designs and control systems for compliance , functionality, and maintainability. + Create or update AutoCAD… more
- LISI MEDICAL Remmele (Coon Rapids, MN)
- …change requests with customers and ensuring compliance with ISO 13485, FDA , and other applicable standards. The Quality Engineer collaborates closely with ... surgery. More than a part. LISI MEDICAL , is recognized for delivering quality products and innovative services to our customers. Committed to its reputation, LISI… more
- Fortrex (MN)
- …safety technologies, such as rapid microbial testing, blockchain traceability, and AI-powered quality control. . **Regulatory Compliance :** Ensure compliance ... in food safety and pathogen control. + Meticulous approach to safety standards, compliance , and quality , ensuring that all solutions meet the highest safety… more
- Balchem (Faribault, MN)
- …key stakeholders. + Follows GMP protocols, regulatory requirements, and works to ensure product compliance with regulatory bodies like FDA . + Be able to travel ... on the planet, providing state-of-the-art solutions and the finest quality products for a range of industries worldwide. Our...the network. The position reports to the Agglomeration PD&A Manager and will participate in a wide variety of… more
- Olympus Corporation of the Americas (Brooklyn Park, MN)
- …If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (###). **Let's realize your potential, together.** It ... desirable. + Able to perform required duties with minimum supervision. + Knowledge of FDA regulations is desirable. + Quality and Customer Oriented. **Why join… more
- Medtronic (Mounds View, MN)
- …regulatory trends and provide guidance to internal stakeholders. Collaborate with R&D, Quality , and other teams to ensure product compliance throughout the ... Affairs Specialist, you will play a key role in ensuring regulatory compliance and supporting the global market expansion of products commercialized by Digital… more
- Medtronic (Minneapolis, MN)
- …adhere to company policies and procedures + Adheres to financial, regulatory, quality compliance standards and requirements. **Influence and Selling:** + ... customers in a manner that adheres to ethics & compliance guidelines and FDA requirements **Communication:** +...regarding product pricing or account activity to District Sales Manager and other appropriate company personnel + Contribute to… more
- Medtronic (Minneapolis, MN)
- …development process rigor to ensure robust understanding of designs, documentation of compliance to requirements and timely, high- quality product launches that ... to ensure robust and appropriate test methods to demonstrate compliance to Design Inputs. + Lead and successfully complete...Medical Device Industry experience. + Familiarity with these regulations: FDA 21 CFR Part 820 cGMP, ISO 13485, ISO… more
- GN Hearing (Bloomington, MN)
- …critical production needs. The role also requires strict adherence to all compliance and regulatory requirements, including participation in CAPA and audit action ... Lead and oversee rework efforts, as required. + Perform quality checks on devices. + Identify and drive improvement...in a regulated environment (ie ISO 9001, ISO 13485, FDA QSR) + Experience with data acquisition/analysis, and demonstrated… more