- Insmed Incorporated (San Diego, CA)
- …of calibration and maintenance systems to ensure operational readiness and regulatory compliance . Responsibilities include leading the procurement, installation, ... and opportunities for productivity improvements.Develop and execute C&Q plans in compliance with internal procedures and regulatory standards.Lead CMMS… more
- Merck & Co. (Rahway, NJ)
- …in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Strategic Leadership and Project ... performance of team members, fostering a collaborative and innovative team environment. Regulatory Compliance and Quality Assurance:Ensure that all activities are… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …work, general instructions on new assignments Knowledge of Automation, GMPs, Compliance , and Regulatory requirements is essential Excellent communication skills ... manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. It's… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a Senior Engineer in Device Design and Process Development group, you will be part of our Research & Development team that designs and develops ... understanding of medical device assembly equipment to enable development of product specific processes and controls with a focus on DFM/DFA principles.Understanding… more
- Merck & Co. (Rahway, NJ)
- …change management.Familiarity with United States and European Union GMP and Safety compliance regulations.Ability to convert new drug product attributes and ... Engineering, Chemistry, Clinical Operations, Customer-Focused, Data-Driven Decision Making, Drug Product Development, Estimation and Planning, GMP Compliance ,… more
- SharkNinja (Needham, MA)
- …key retailers, online and offline, and through distributors around the world. The Senior Product Safety & Compliance Engineer will have a direct partnership ... product developers and certification partners for all aspects of regulatory compliance and product certification. The candidate will be responsible for… more
- SearchPros (Everett, WA)
- …contribute to Client product safety by maintaining and restoring compliance with regulatory requirements. Investigations typically follow the Client Problem ... Job Description: 100% Onsite Everett WA As an engineer in the Client Commercial Airplanes (BCA) Safety...detailed Root Cause Corrective Action (RCCA) investigations related to regulatory compliance issues. This activity enables program… more
- SGS (Suwanee, GA)
- …of energy storage and battery-powered technologies? Join SGS North America as a Safety Engineer in our Regulatory Battery Compliance team, where you'll be ... spanning consumer electronics, electric vehicles, renewable energy, and more. Be a Compliance Trailblazer : Stay ahead of regulatory changes and emerging… more
- BioSpace (Norwood, MA)
- …contributor responsible for the ownership, operability, and reliability of GMP Drug Product manufacturing process equipment at Moderna's clinical drug product ... preparation, formulation, aseptic filling, inspection, and packaging activities. The engineer is accountable for ensuring equipment readiness, supporting deviation… more
- AbbVie (Worcester, MA)
- …System (MES) platform like POMS. Conversant with industry standards on quality and regulatory compliance requirements such as 21 CFR Part 11 (Data Integrity, ... productivity and quality and safety performance. In this dynamic role the Automation Engineer will ensure the success of Drug product manufacturing through an… more
- Adidev Technologies Inc (New York, NY)
- …best practices, including AutoML, MLOps, and interpretability frameworks. *Promote compliance with industry standards and regulatory requirements, emphasizing ... Role: Jr-Mid Machine Learning Engineer (This role is open to US Citizens,...to integrate Generative AI models into our offerings, enhancing product capabilities and user experiences. *Apply advanced analytical techniques… more
- Kasmo Global (Mossville, IL)
- …standards, compile evidence, and guide compliance activities throughout the product lifecycle. Key Responsibilities: Interpret and apply regulatory and ... Job Title: Compliance Engineer (x2) Location: Mossville, IL...validation phases. Ensure engineering validation and test reports satisfy regulatory requirements. Collaborate with product development, testing,… more
- Cepheid (Sunnyvale, CA)
- …the Danaher Business System which makes everything possible. The Senior Quality Engineer is responsible for driving manufacturing and product lifecycle quality ... by implementing a risk-based approach to ensure compliance with corporate policies, 21 CFR 820, ISO 13485,...corporate policies, 21 CFR 820, ISO 13485, and other regulatory standards, while championing continuous improvement. You will play… more
- Noah Medical (San Jose, CA)
- …and comply with all relevant aspects of Noah Medical Quality Management System to ensure product and support regulatory compliance . As the voice of quality, ... Medical, where you'll play a pivotal role in driving innovation and product leadership in medical robotics. We're a hands-on, technical, and solution-oriented, and… more
- Boston Scientific (St. Paul, MN)
- …We have an exciting opportunity for Senior Design Quality Engineer supporting Medical Electrical Equipment within Boston Scientific's Electrophysiology Division. ... In a hybrid or on-site work mode, the Senior Design Quality Engineer will work cross-functionally to ensure safety, quality, and compliance of Legacy Medical… more
- SI-BONE, Inc (Santa Clara, CA)
- … product development activities Support all technical aspects of the product and instruments. Support regulatory requirements. Support design control process. ... of a medical device business emphasized on engineering, manufacturing, operations, R&D, product marketing, clinical and regulatory , and quality assurance. Be… more
- Stantec (Boston, MA)
- …budget and their schedules for completing the work in conjunction with Project Manager(s). Engineer of record on own work product , work of non-licensed engineers ... Grow with us, H2O+U. Your Opportunity We are looking for a talented Process Engineer , who wants to be part of a purpose-driven organization that's focused on helping… more
- Coastal Villages Region Fund (Seattle, WA)
- …and ventilation systems Operate boilers and steam generation systems Assists the Chief Engineer in ensuring compliance with all US Coast Guard manning, watch ... Coastal Villages Region Fund, is currently seeking applications for a First Assistant Engineer to work aboard the F/T Northern Hawk. The primary responsibilities of… more
- Katalyst HealthCares and Life Sciences (Waltham, MA)
- …up-to-date product process documentation and assure they are in compliance with applicable procedures and regulations. Writes justification memos and scientific ... and ensure they are in compliance . Generate and review reports to provide required information to regulatory agencies such as Annual Product Review. more
- Katalyst HealthCares and Life Sciences (San Diego, CA)
- … development and modify / update existing products. Lead cross-functional teams to address product compliance related issues. Define and lead all aspects of the ... technical regulations, directives and standards. Review new and existing designs for compliance to the latest directives and standards. Oversee lab control and… more
