- Merck & Co. (Rahway, NJ)
- Job Description Job Description As a Design Control and Risk Management Data Manager, you are a key member of the Device Development Team. Your will main ... Key responsibilities include the following: Partner with the Design Control and Risk Management leads to determine the data relationships and… more
- Merck & Co. (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 will be responsible for leading and implementing medical device and combination product design controls and risk management activities for both new… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and implement modifications to risk assessment plans.Key Responsibilities Follow QRM (Quality Risk Management ) process per ICH Q9, identify the risk , ... risk , evaluate the risks and work resources to control the risks based on failure analysis resultsPlan and...required resourcesServe as leader and prime advocate for your Risk Assessment, design , manage, support and direct… more
- Tris Pharma (Monmouth Junction, NJ)
- …implement improvements, including CAPAs and CPIs, across departments as appropriateApplies quality risk management principles in the design (and resolution) ... New Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, Quality Management Systems (QMS) supports,… more
- Merck & Co. (Rahway, NJ)
- …2 years of experience with Cybersecurity concepts, including encryption, configuration management , auditing, access control , database security and information ... around the use of new cloud features to establish an acceptable risk posture. Define the requirements, best practices, and lead the collaborative development… more
- Merck & Co. (Rahway, NJ)
- …technical documentation in support of the following: process performance qualification, risk assessment, control strategy, process comparability reports, and/or ... Coordinate project planning, resourcing, progress reporting, troubleshooting and people management .Serve as the scientific/technical mentor for junior staff.- Provide… more
- Merck & Co. (Rahway, NJ)
- …Analytical Research & Development (AR&D), Design Controls & Risk Management (DCRM), Quality, Regulatory, and Quality Control (QC) facilities to ensure ... technical rigor to support development, IND-enabling stability, commercial stability, and Design Verification. This role involves leading the method tech transfer… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/ Risk Management , Quality Assurance, Medical Affairs, Translational ... Research, Research, Informatics Services Project Management and Operational Management .Develop a strong, positive strategic business partnership with the global… more
- Novo Nordisk Inc. (Boulder, CO)
- …patients Work effectively across all departments, such as Quality Assurance/ Control , Chemical Development, Program Management , Regulatory, Quality Control ... will work with CMO's to ensure the continuous supply of product and apply risk mitigation strategies, as well as perform formulation studies in a laboratory setting… more
- Danaher Corporation (Coralville, IA)
- … process improvements and act as resource for colleagues in explaining design control and risk management concepts and requirements; may include coaching ... and developing proficiency in the use of design control and risk management principals/ processes to establish the best approaches to problems. The… more
- Hologic (Newark, DE)
- …Engineer** to join our dynamic team. In this role, you will leverage your expertise in design control , risk management , quality systems, and change ... to the design and maintenance of our medical devices through rigorous design control , risk management , quality systems, and change management … 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
- Bausch + Lomb (St. Louis, MO)
- …System Engineer further provides system-level oversight and high-level management of all design control , risk management , and usability engineering ... used throughout the product life cycle to manage design control (DHF/DMR), risk management , and usability engineering documents and specifications. *… more
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …other relevant tasks. PM I/II is competent in design control , change control , and risk management as they relate to medical device development and/or ... + Manages and tracks project or program budget. + Utilizes knowledge of BioFire products, design control , risk management and change control to draft… 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
- Edwards Lifesciences (Irvine, CA)
- …leadership for successful new product development projects by applying design control and risk management principles to positively influence new ... to commercialization (Class III preferred). + Experience with Risk Management and Design Control + Working knowledge of the Domestic and International… more
- Edwards Lifesciences (Irvine, CA)
- …Quality Engineering input to THV commercialized product projects including application of design control and risk management + Be a subject matter expert ... THV products. This includes support of product configuration changes, providing design control expertise for manufacturing improvements, leading investigations… more
- Wells Fargo (Charlotte, NC)
- … management activities within the Asset Based Lending Group including control design , risk assessment and issues management . This position is a direct ... will:** **Participate in identifying, assessing, managing, and mitigating current and emerging risk exposures within Control Management functional area**… more
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …+ COMSOL + Minitab Knowledge, Skills, and Abilities + Advanced knowledge of BioFire products, design control , risk management , and change control . ... generally considered within the realm of instrument and fixture design . They are expected to communicate well with other...+ Communicate project status to team members and to management . + Present project-related updates to large groups and… more
- WSP USA (Los Angeles, CA)
- …PMO business + Develop Project Management Plans to include Program Controls, Document Control , Design Management , Risk Management , Safety ... **This Opportunity** Join our growing Program Management Team that meets our client's objectives and...+ Bachelor's degree in engineering or similar + Extensive Design -Build project delivery experience as a Program Manager or… more
