- Kelly Services (Plymouth, MN)
- …transfer from R&D to manufacturing. + Working knowledge of FDA Design Controls and ISO 13485 Quality Management Systems. + Working knowledge of ANSI/AAMI/ ISO ... history files. + Perform change control assessments. + Work closely with project manager and technical lead to achieve project commitments. + Adhere to design… more
- Northrop Grumman (Plymouth, MN)
- …Reviews + Coordinate manufacturing efforts between internal functional disciplines including Engineering , Supply Chain, Quality , Manufacturing, and Test. + Work ... Precision Guidance Ordinance. **Position Description** This position provides multifunctional engineering guidance and support for manufacturing of current products,… more
- Northrop Grumman (Plymouth, MN)
- …remotely part time with manager approval. + Work effectively with engineering , and materials & processes, supplier quality and sub-contracts organizations to ... 6 years of experience. + Previous experience working with engineering , and materials & processes, supplier quality ...and capture teams. + Experience in reviewing a supplier's ISO and QMS systems to ensure they can meet… more
- Medtronic (Brooklyn Center, MN)
- …your professional development and growth. Reporting to the Connectors Engineering Manager , you will focus on enhancing manufacturing quality , reducing lead ... Quality System Regulations, current Good Manufacturing Practices (cGMP), ISO 13485, ISO 9001 standards or equivalent....computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions… more
- Olympus Corporation of the Americas (Brooklyn Park, MN)
- …system as required (Including New Catalog & Item numbers, Bills of Materials, Engineering Changes and Deviations). + Work with Document Control team(all sites) and ... other departments to support quality and standardization of OSTA documentation process. Promote continuous...meeting Good Documentation Practices based on OSTA QSR documents, ISO 13485, FDA 21 CFR 820. + Meet deliverable,… more
- CDM Smith (Bloomington, MN)
- …41662BR **Business Unit:** TSU **Job Description:** CDM Smith is a multi-discipline engineering and architectural firm. Our firm is responsible for large-scale flood ... the work of others and as an individual contributor. - Perform engineering services during construction, including review of shop drawing submittals and response… more
- Medtronic (Minneapolis, MN)
- …but are not limited to:** + Maintain a thorough knowledge and understanding of ISO 14971 and risk management practices, such as Hazard Analysis and Failure Mode and ... teams (including Design, Human Factors, Medical Safety, Reliability and Post-Market Quality ) to ensure that all hazards associated with medical devices are… more
- Medtronic (Minneapolis, MN)
- … 14971, ISO 13485, and other global regulatory requirements and quality standards + History of successful device submissions + Strong negotiation skills and ... with supervisor, as necessary, and resolve submission issues with Medtronic engineering partners, Medtronic Geography Regulatory partners, and regulatory agencies as… more
- Wabtec Corporation (Hibbing, MN)
- … Engineering , Drafting, Design and Applications an will report directly to the Quality Assurance Manager . **How will you make a difference?** This position is ... Dimensioning and Tolerancing) qualities to ensure that they meet engineering and customer specifications. **What do we want to...recording of inspection findings. + Ensure compliance to all ISO 9001 quality standards. + May be… more
- Teleflex (Minneapolis, MN)
- …needed support material for members of the sales team * Comply with FDA and ISO Quality Systems requirements. * Account for all territory expenses and materials. ... 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… more
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