- Abbott (Plymouth, MN)
- …collaboratively communicating & resolving gaps. + Serve as a front-room representative during internal and external inspections and inquiries from regulators such ... as FDA and ISO as it relates to design assurance. + Support...requirements. + Support all Company initiatives as identified by management and in support of Quality Management … more
- Abbott (Alameda, CA)
- …overall responsibility for Complaint Handling. They are the subject matter expert and representative for the Formally Designated Unit (FDU) and serve as a primary ... agencies, globally. Works closely with Commercial Teams and Commercial Senior Management to ensure that worldwide Customer Service functions follow global… more
- ITW (Gallatin, TN)
- …improvement efforts. + Direct contact for plant floor interface with management + Participate in quality planning/manufacturing process review as needed (APQP). ... maintenance of computer hardware and software related to data collection and management for determination of product quality and process capability. + Review control… more
- Olympus Corporation of the Americas (Brooklyn Park, MN)
- …with Manufacturing Quality Assurance. + Acts as supplier quality engineering representative in new product development projects. + Performs Advanced Product Quality ... material review boards. + Supports facility audits by outside agencies (ie, FDA, ISO / MDSAP). + Supports Supplier audits as co-auditor. + Performs local supplier… more
- Danaher Corporation (Sunnyvale, CA)
- …quality systems activities related to assay development, specially design control and risk management activities in accordance with FDA and ISO regulations. This ... role, you will have the opportunity to: + Participate as Quality representative on product development teams which includes providing guidance for Market… more
- Philips (Orange, OH)
- …FDA, SFDA, KFDA, JPAL, and notified bodies). + Serve as Regulatory Affairs representative for CT/AMI Systems, guiding risk management , defect and complaint ... compliance with relevant regulations. They provide regulatory guidance on risk management , labeling, design, and audits, supporting both sustaining and new product… more
- dsm-firmenich (St. Louis, MO)
- …and procedures. Maintaining a safe and clean work environment * Ensure adherence to all management systems including, ISO 9001:2015, ISO 14001 and ISO ... utilizing maintenance computer software and interact regularly with peers and management to pursue continuous improvement of facility operations * Operating… more
- Cook Medical (Spencer, IN)
- …or a Technical Life Science Degree.- Demonstrates knowledge of medical device regulation ( ISO 13485, 21CFR) and risk management ( ISO 14971)- Professional ... Overview The Quality Engineer serves as the lead quality representative of certain product lines within product development, manufacturing, post-market surveillance,… more
- Cook Medical (Bloomington, IN)
- …degree and 5-8 years of experience- Demonstrates knowledge of medical device regulation ( ISO 13485, 21CFR) and risk management ( ISO 14971)- Professional ... Overview The Quality Engineer serves as the lead quality representative of certain product lines within manufacturing. Responsibilities - Perform work per external… more
- Cook Medical (Canton, IL)
- …quality engineering experience from any regulated industry.- Knowledge of medical device regulation ( ISO 13485, 21CFR) and risk management ( ISO 14971) is ... Overview The Manufacturing Quality Engineer serves as the lead quality representative of assigned product lines for new product development, day to day manufacturing… more
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