- 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
- Merck (Rahway, NJ)
- **Job Description** As a Design Control and Risk Management Data Manager, you are a key member of the Device Development Team. Your will main ... responsibilities include the following:** + Partner with the Design Control and Risk Management leads to determine the data relationships and mapping.… 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 (Minneapolis, 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
- Gilead Sciences, Inc. (Foster City, CA)
- …/ combination product expert who provides safety oversight and technical contribution to design control , risk management , clinical evaluations, ... product regulations and industry standards globally for design control , device risk management , vigilance / safety reporting, and post-market… 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
- 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
- Ricoh Americas Corporation (Parma, OH)
- …and statistical analysis. + Experience with product and process validation, design control , and risk management . + Knowledge and experience with additive ... with customer requirements, internal procedures, and acceptance criteria, while meeting all design control and other regulatory requirements. **JOB DUTIES AND… 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
- Tecomet (Wilmington, MA)
- …new and unique engineering methods and procedures - Lean, Six Sigma, root cause analysis, Design Control , Risk Management , etc. - Responsible for product ... processes and lean manufacturing initiatives. Accountable for the creation, development, design and improvement of products in conformance with all regulations… more