- Merck & Co. (Rahway, NJ)
- …and combination products globally.- Experience in design controls, device risk management , medical device , complex combination product kits, prefilled ... sustainmentof medical devices ...plus years in design control, risk analysis and change control management for medical device or combination… more
- Merck & Co. (Rahway, NJ)
- …device development activities including engineering design, engineering analysis and testing, medical device design controls, risk management , test ... and leading cross-disciplinary project teams.Has broad knowledge of medical device development, design controls and risk management , alongside deep knowledge… more
- Merck & Co. (Rahway, NJ)
- …and managing external vendors/research partners.Preferred Experience and Skills:Experience with medical device development with understanding of Design Controls ... Job DescriptionOur Company's Device Product and Process Development (DPPD) Team is...(21 CFR 820.30)Familiarity with the following standards: Quality Management - ISO 13485, Risk … more
- Merck & Co. (Rahway, NJ)
- …and managing external vendors/research partners.Preferred Experience and Skills: Experience with medical device development with understanding of Design Controls ... Job DescriptionJOB DESCRIPTION Our Company's Device Product and Process Development (DPPD) Team is...(21 CFR 820.30)Familiarity with the following standards: Quality Management - ISO 13485, Risk … more
- Novo Nordisk Inc. (Durham, NC)
- …&/or packaging systems required, preferably in the pharmaceutical or medical device field Demonstrated expertise in Regulations & quality systems (eg, ... 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases,...Ability to support all processes & functions in Department Quality Risk Management Makes decisions on … more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …possess strong knowledge manufacturing within a regulated industry such as medical device , automotive, or defense.Must be detail-oriented with exceptional ... Position SummaryThe Quality Engineer is responsible for overseeing the health...CAPAs, CAPA On Time, and Validation on Time.Job ResponsibilitiesChange Management - evaluate the impact to product, processes, and… more
- Twist BioScience (South San Francisco, CA)
- …in the genomics industry will be a plus.Experience with FDA regulations for medical devices and IVD devices .Experience with EU regulations for ... We are seeking a highly experienced and motivated Staff Quality Engineer join our dynamic team. As a Staff...least 5 years of experience in a supervisory or management role.Proven ability to lead and manage projectsStrong analytical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …database and data validation programming and/or related work experience in a medical device , biotech, or pharmaceutical company, or similar environment (eg, ... validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …company expectations for products. The incumbent is responsible to adhere and maintain Quality Management System and GMP Compliance Programs to assure product ... preferred Experience Qualifications4 or more years in pharmaceutical, biological and/or medical device operations including first-hand knowledge of drug… more
- Aequor (Thousand Oaks, CA)
- … quality assurance or manufacturing experience in a GMP pharmaceutical or medical device industry. Evaluate documentation and operation according to company ... mathematical skills including the ability to trend data. Basic project management skills. Independently understand, follow and implement instructions. Written and… more
