- Insight Global (Rahway, NJ)
- …One of our large pharmaceutical clients is actively hiring a Design Control and Risk Management lead, supporting the Combination Product, Device ... for leading and implementing Medical Device & Combination Product Design Control & Risk Management activities for new products from early design … more
- Insight Global (Rahway, NJ)
- …Description One of our large pharmaceutical clients is actively hiring a Design Control and Risk Management Engineer on the Combination Product Team, ... Responsibilities: - Lead the creation of Device Development, Design Control and Risk Management deliverables for the assigned projects. - Lead the… more
- Merck (Rahway, NJ)
- …will be expected to apply his/her knowledge of product development, design control principles and risk management techniques to positively support and ... **Position Description:** **Device Development Associate Principal Scientist - Development Strategy, Design Controls and Risk Management ** Our company's… more
- Philips (Plymouth, MN)
- …years' experience working within FDA regulated medical device environments, with a focus in design control /assurance, risk management , FMEA's, PHA's etc. ... and process validation planning as well as quality system compliance. + Ensure Risk Management is effective utilizing feedback from validation, field service,… more
- Cordis (Miami Lakes, FL)
- …projects, as applicable. + Support External Audits in areas of Design Control , Product Risk Management , and Recent Project Launches, as applicable. ... demonstrate understanding and/or application of Design Controls, Process Validation, Risk Management , and Change Control . + Must possess experience with… more
- Actalent (Fridley, MN)
- …working with cross-functional development teams to establish and maintain design control deliverables, risk management activities, and DHF compliance, ... design verification and validation planning. + Will be performing risk management activities, design tests and inspection method development. +… more
- Fresenius Medical Center (Lawrence, MA)
- …Assist in the development and maintenance of company procedures for design control , change managements, risk management , process validation and related ... Master Record (DMR) reviews meetings and fully understand the design control process and Quality Engineering. Utilize... design verification, validation, specification and procedure development, risk management , and design review.… more
- Fresenius Medical Center (Lawrence, MA)
- …Assist in the development and maintenance of company procedures for design control , change managements, risk management , process validation and related ... File (DHF) and review meetings and fully understand the design control process and Quality Engineering. Utilize... design verification, validation, specification and procedure development, risk management , and design review.… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- …implementation of corrective actions to mitigate recurrence. + Contribute to design control and risk management for data workflows, within the context ... Regeneron is looking for a Sr. Manager QC (Quality Control ) focusing on HPLC. This position supports QC Chemistry...QC Lab quality and compliance subject matter expert, driving risk -based actions and improvements, in alignment with the strategic… more
- Edwards Lifesciences (Irvine, CA)
- …Development programs + Provides engineering solutions in the areas of Quality Assurance, Design Control , Risk Management , and Statistical Techniques. ... + Develop, update, and maintain technical content of risk management files + Collaborates cross-functionally (eg. R&D, Mfg/Ops, Regulatory) to help facilitate… more
- AbbVie (North Chicago, IL)
- …with AbbVie's software lifecycle policies and procedures. * Perform design control and risk management activities (including cybersecurity risk ... System * Partner with technical teams to ensure design control documentation ( Risk Management , Traceability/Linkages) & design change control… more
- AbbVie (Irvine, CA)
- …+ Ensure compliance with company policies and procedures. + Perform design control and risk management activities according to AbbVie's Quality System ... + Partner within Quality and R&D to ensure design control documentation ( Risk Management , Traceability/Linkages) & design change control … more
- Precise Solutions (Lake County, IL)
- …with the client's software lifecycle policies and procedures. + Perform design control and risk management activities according to the client's Quality ... System + Partner with technical teams to ensure design control documentation ( Risk Management , Traceability/Linkages) & design change control … more
- 3D Systems, Inc. (Littleton, CO)
- …Engineer) desirable. * Experience with product and process validation, design control , and risk management . * Excellent problem-solving and analytical ... quality of incoming materials and components. * Maintain accurate quality documentation, including design history files, risk management files, and test… more
- Discover (Riverwoods, IL)
- …and escalates risk and customer-impacting issues to management . **Responsibilities** Risk and Control Design + Provides education and monitors ... timely completion of control design reviews, process management reviews , risk and control self-assessments, and enterprise risk assessments.… more
- Zimmer Biomet (Warsaw, IN)
- …+ Authors, presents and obtains cross-functional team member approval of design control and risk management documentation as part of the product ... design requirements, associated user risks and the design itself to ensure appropriate quality control ...+ Evaluates, verifies and validates product designs relative to design requirements and to reduce user risk … more
- AbbVie (Irvine, CA)
- …+ Ensure compliance with company policies and procedures. + Perform design control and risk management activities according to AbbVie's Quality System ... Quality and Research & Design (R&D) to ensure design control documentation ( Risk Management , Traceability/Linkages) & design change control … more
- Danaher Corporation (Sacramento, CA)
- …development projects. + Proven knowledge of design control processes, including design change, risk management , design requirements, design ... and approving design history file documents and owning product safety risk management deliverables. This is not a software testing role. You will be part… more
- Epic Sciences (San Diego, CA)
- … skills. Execution: Demonstrated effectiveness at providing practical guidance, design control , and risk management expertise to facilitate project ... testing and design verification to appropriate standards + Evaluate and establish risk management standards to support project management goals in line… more
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …+ Deep understanding of panel development process + Understanding and demonstrated experience with design control , risk management , and change control ... The Program Director leads the program management and lifecycle management of the programs that compose the BioFire IVD Panels portfolio including all aspects of… more