- Twist BioScience (South San Francisco, CA)
- …GCP) and DevOps practices.Direct experience participating in regulatory audits (eg, FDA inspections) specifically related to custom software and CSV.Experience ... across our biomanufacturing operations. This critical role will drive efficiency, quality , and robust data integrity within a highly automated environment. The… more
- Merck & Co. (Rahway, NJ)
- …(Research & Development) by:Developing an active engagement strategy with US FDA and global health authorities to advocate advanced regulatory strategies for ... efficiently on regulatory obligations, compliance requirements and company strategy.Providing quality advice to stakeholders creating optimal development, commercialization, and… more
- Merck & Co. (Rahway, NJ)
- …global human health.Responsibilities: The Senior Statistical Programmer, Submission Data Standards Quality Management (SDS QM), provides oversight and quality ... process and providing tools and templates to support delivery focusing on traceability, quality assurance, data conformance and data fitness. The position is a key… more
- Tris Pharma (Monmouth Junction, NJ)
- …and advances required documentations, in liaison with Product Development (PD)/ Quality Assurance (QA)/ Quality Control (QC)/Regulatory Affairs, including ... Executes studies and prepares technical protocols/reports in response to FDA Information Requests (IRs)/Complete Response Letters (CRLs)Cleans, maintains and… more
- Formation Bio (New York, NY)
- …high-value negotiations with vendors across multiple categories, including software , contract research organizations (CROs), contract manufacturing organizations ... company. Monitor vendor performance and enforce contractual obligations to maximize service quality and efficiency. Partner with Legal, Quality Assurance and… more
- Insmed Incorporated (San Diego, CA)
- …and validation according to regulatory guidelines such as ICH, FDA , and cGMP, evaluating method characteristics like specificity, sensitivity, accuracy, ... and maintains detailed records. Analyzing data, preparing reports, and using statistical software for trend analysis are also key duties. Collaboration with R&D,… more
- Eisai, Inc (Nutley, NJ)
- …to the company's products. The incumbent will contribute to the development of high- quality Medical Information deliverables within the team and will be a visible ... to 2 years of relevant experience.Prior understanding and knowledge of FDA guidances on appropriate scientific exchange practices.Demonstrated experience in medical… more
- Merck & Co. (Rahway, NJ)
- …team environment with key stakeholders across the organizations such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression of ... of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory, Operations, Non-clinical, Clinical, and other functional areasExperience… more
- Aequor (Hicksville, OH)
- …and any other quality or regulatory requirements. (For example: OSHA, DEA, FDA , EMEA, ANVISA, HS&E, etc.) Note: This position may require the labeling, packaging ... observing all safety regulations and ensuring all cGMP and quality standards are met and to maintain the efficient...and recommend improvements. Ability to learn and apply new software multimedia applications Ability to lift up to 50… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …and PAS-X/SAP related projects. He/she will work with Planners, Manufacturing, Facilities, Quality Control, MSAT, and Engineering to support and improve the planning ... plant, proactively, show a LEAN mindset Interface with Production, Quality Control and Facilities to assist API Planning activities...Knowledge, Skills, and Abilities Knowledge of Cgmp's, ISO and FDA requirements a plus Able to develop and manage… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …tasks on time in a manner consistent with safety policies, quality systems, and cGMP requirements.Build strong partnerships with Manufacturing, Warehouse, ... Engineering, and Quality , and work as part of a cross-functional team...industry.Proficient computer skills to be able to navigate specialized software and databases.An ability to build strong partnerships and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …etc.).Coordinate and execute MES validation activities according to the Software Development Lifecycle (eg commissioning test Plans (CTP), Installation/Operational ... with alignment to Global Procedures.Act as a Site MES SME to support Quality Investigations, Corrections, and QMS records.Build the Site Readiness of MES for … more
- Genmab (NJ)
- …consistency and adherence to standards of data and produces well-structured, high quality data summaries in tables, figures and listings for decision making. ... non-comprehensive list of deliverables: IB, DSUR, briefing packages for FDA , EMA etc., supplementary in-house preparations for DMC-meetings, RP2D- selection… more
- Abbott (Westfield, IN)
- …and work experience **Experience/Background** + Minimum 2 years of Software Quality Engineering experience + Detailed knowledge of FDA , GMP, IEEE 1012 ... Our 114,000 colleagues serve people in more than 160 countries. **Engineer II Software Quality ** **About Abbott** Abbott is a global healthcare leader, creating… more
- Abbott (Sylmar, CA)
- …Our location in **Sylmar, CA** , currently has an opportunity for a ** Software Quality Engineer II** **.** This position is responsible for executing ... integrity risks. + Follow approved Design Control procedures for software development in accordance with FDA guidelines....education and work experience + Minimum 2 years + Software Quality Engineering experience + Prior medical… more
- US Tech Solutions (San Bruno, CA)
- …standards and corporate requirements. **Regulatory Compliance:** 1. Ensure compliance with US FDA Quality System Regulations, ISO 13485, and integration of best ... understanding of medical device software standards such as IEC 62304. ** Software Quality Engineering Expertise:** 1. Hands-on experience in Software … more
- Abbott (Burlington, MA)
- …health and get on with their lives. We are seeking an experienced **_Staff Software Quality Engineer_** to ensure our medical devices are developed in accordance ... oversight for Software Development projects. The **_Staff Software Quality Engineer_** is responsible for executing...FDA regulations and guidance, ISO 13485, ISO 14971, Software Standards (eg, 62304), EU Medical Device Regulations and… more
- Stryker (Portage, MI)
- **Stryker** is hiring a **Staff Software Quality Engineer, Design Assurance** to support our Medical's Digital Health division and portfolio Software as a ... (SiMD) to execute on Digital Health projects as a software design quality assurance engineer for pre-market...improvement across the software lifecycle by implementing software industry best practices and regulatory standards ( FDA… more
- Stryker (Weston, FL)
- **Senior Staff, Software Quality Assurance Engineer** Stryker is seeking a Senior Staff Software Quality Assurance Engineer to support our Digital ... with R&D software development teams to guide them through internal quality system processes and ensure compliance with regulatory standards, including FDA ,… more
- Fresenius Medical Center (Lawrence, MA)
- …Agile methodology desired but not required. . Thorough understanding of FDA Quality System regulations in relation to software development and validation or ... as 21CFR 820.30, IEC62304:2016 amd.1, IEC81001-5-1, as well as FDA and MDCG guidance. . Responsible for the planning...experience in software engineering, information technology, or software quality assurance in a regulated environment;… more
