- Abbott (St. Paul, MN)
- …lower level engineers. + Execute on Holistic & Strategic Design Verification/ Validation Strategies with emphasis on: + Technical analysis of requirements, ... specifications, and control strategy + Efficient and cost-effective execution of validation and verification + Alignment of design outputs to production and process… more
- Abbott (Plymouth, MN)
- …You'll Work On** + Execute on Holistic & Strategic Design Verification/ Validation Strategies with emphasis on + Technical analysis of requirements, specifications, ... and control strategy + Efficient and cost-effective execution of validation and verification + Alignment of design outputs to...and external inspections and inquiries from regulators such as FDA and ISO as it relates to design assurance… more
- TE Connectivity (Plymouth, MN)
- …and associated Standard Operating Procedures (SOPs). Develop and execute to Validation Master Plans, Equipment Qualifications, Process Validations, and test method ... Requires 1 year of experience with the following: 1. Quality compliance guidance per FDA QSR (21 CFR 820) and ISO 13485. 2. Quality engineering knowledge in medical… more
- TE Connectivity (Plymouth, MN)
- …and associated Standard Operating Procedures (SOPs). Develop and execute to Validation Master Plans, Equipment Qualifications, Process Validations, and test method ... Requires 1 year of experience with the following: 1. Quality compliance guidance per FDA QSR (21 CFR 820) and ISO 13485. 2. Quality engineering knowledge in medical… more
- Actalent (Minneapolis, MN)
- …device, Design assurance, Iso 13485, Design control, Risk management, Design validation , Validation , Quality engineering Additional Skills & Qualifications - ... CE Marking, EN ISO 5840, EU MDR (formerly MDD), FDA Medical Device Regulation (MDR), and FDA ...MDD), FDA Medical Device Regulation (MDR), and FDA requirements. - Extensive knowledge of manufacturing processes and… more
- Olympus Corporation of the Americas (Brooklyn Park, MN)
- …team. + Assists in the implementation compliance and maintenance of standards (eg FDA IS0 13485) and OSTA Quality policies and procedures. + Trains location ... metrology component inspection methods and preventive maintenance programs. + Supports validation and verification strategy for new and existing products and… more
- Olympus Corporation of the Americas (Brooklyn Park, MN)
- …Control activities for new product development efforts. + Support Process/Design Validation Nerification activities and approach including software validation . + ... + Minimum of 5 years of experience in Quality Engineering within an FDA regulated medical device manufacturing environment. + Strong working knowledge of technical… more
- ARUNDEL MACHINE (Minneapolis, MN)
- …to ensure the products manufactured meet customer requirements and specifications, including FDA , ISO 13485 and AS compliance, as applicable. This position will ... day 1! Generous 401k match. Primary Responsibilities * Quality management representative for FDA 21 CFR 820, ISO 13485 and AS9100 certifications. Maintain records of… more
- Abbott (Plymouth, MN)
- …and submit medical device submissions to regulatory agencies + Interfaces directly with FDA and other regulatory agencies. + Acts as liaison between the Company and ... to appropriate personnel. + Reviews device labeling for compliance with FDA submissions and applicable regulations. + Supports the product release process… more
- Olympus Corporation of the Americas (Brooklyn Park, MN)
- …product feasibility testing, technical risk reduction planning, design verification and validation testing strategy and testing efforts, lead or contribute to design ... User and Product Requirements. + Experienced in planning Design Verification and Validation efforts to ensure the product effectively meets all requirements and… more