- Merck & Co. (Rahway, NJ)
- …cross-functional impact, including drug device /combination products and software as medical device platforms.- Reviews and resolves issues that span diverse ... (Research & Development) by:Developing an active engagement strategy with US FDA and global health authorities to advocate advanced regulatory strategies for… more
- Merck & Co. (Rahway, NJ)
- …robust scientific methodology we collaborate to discover and develop the next medical breakthrough. Our Company's success is backed by ethical integrity, forward ... (PSCS) deliverable which is the development of robust compositions, processes and device / packaging that enable patient centric products for patients. The successful… more
- MicroVention (Aliso Viejo, CA)
- …and data analysis. Demonstrated command and knowledge of FDA and ISO medical device quality system requirements. Proven experience in statistical ... control, risk analysis, design verification, and design validation. Strong knowledge of medical device design control process. Ability to understand the… more
- LanceSoft (Dublin, OH)
- …be familiar with and comfortable using computers. *Working knowledge of the medical device regulatory procedures, lean manufacturing, and manufacturing processes ... business practices and company documented procedures (including but not limited to FDA , Quality Systems Regulations, ISO 13485, ISO 14001, government… more
- Cresilon, Inc. (Brooklyn, NY)
- …to save lives. Learn more about the company at www.cresilon.com. Description: The Medical Device Engineer is responsible for leading the design and development ... and fabrication and data generation through designed experiments. The Medical Device Engineer is expected to aspire...invention disclosures. Ensure that all design activities adhere to FDA Quality System Regulations and ISO 13485… more
- RQM+ (Santa Clara, CA)
- …and work experience 7-9 years of project management experience Comprehensive knowledge of medical device design controls and Quality Management Systems. ... be responsible for leading cross-functional projects from concept to commercialization for medical device and technical business projects. This individual will… more
- AbbVie (Pleasanton, CA)
- … FDA 's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which ... our talent pipeline and considered for future opportunities. The Device Engineer will work collaboratively with a team to...work collaboratively with a team to design and develop medical products from initial concept through the transfer to… more
- RESILIENCE (West Chester, OH)
- …and Kaizen events, manual data collection) to achieve a prescribed level of purity, quality , and consistency in product and work output in accordance with cGMPs. Job ... move, store or deliver material to the proper location. *Perform visual quality inspection and sampling of in-process materials. Promptly escalate concerns to Lead… more
- BayOne (Raleigh, NC)
- …Americans with Disabilities Act (ADA). Work Experience 7 - 8 years of relevant Quality medical device development experience Energy-Based Device ... and R&D overall to assure global compliance. Including: * Quality activities for medical device ...to effectively multitask and manage multiple projects Experience with FDA , European agency regulations, cGMP regulations, and Quality… more
- EPM Scientific (San Carlos, CA)
- …degree in Engineering or related technical field (Master's preferred) 8+ years of experience in medical device quality engineering, with at least 3 years in ... Principal Quality Engineer Location: Bay Area Full-Time | Onsite...Full-Time | Onsite Join our mission-driven team, a pioneering medical device company specializing in radiotherapy systems… more
- Santa Cruz Nutritionals (Santa Cruz, CA)
- …engineering project management, or similar role in the nutraceutical, pharmaceutical, food, or medical device industry. ASQ Certified Quality Engineer (CQE) ... quality control or assurance in the nutraceutical, pharmaceutical, food, or medical device industry. Experience with Lean, Six Sigma, QC/QA methodologies,… more
- Actalent (Irvine, CA)
- …and ISO regulations. Additional Skills & Qualifications Knowledge of neurovascular and medical device quality engineering. Experience with system ... system changes and continuous improvement activities associated with the Legal Manufacturer quality system to comply with ISO: 2016, FDA QSR/QMSR (effective Feb… more
- MicroVention (Aliso Viejo, CA)
- …field. Minimum six (6) years of direct clinical research experience, preferably in the medical device industry, including at least two (2) years of monitoring ... in various therapeutic areas (preferred areas: Neurovascular and/or Cardiovascular). Experience in the medical device industry. At least two (2) years of project… more
- Katalyst HealthCares and Life Sciences (Belleville, NJ)
- …of US and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human Factors ... Previous experience in inhalation drug delivery. Has broad knowledge of medical device development, design controls and risk management. Led and managed… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …training requirements, demonstrate understanding, and follow instructions exactly as required by medical device regulations. Is coachable - responds to coaching ... TherOx Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to...output requirements. Since required training and knowledge testing for medical device processing is conducted in English,… more
- LanceSoft (Minneapolis, MN)
- …working in a regulated environment. Experience working in a medical device environment. Experience working with FDA , ISO, EN, and/or GMP standards. ... (RA) works under general supervision to prepare, process, and implement quality systems, configuration management, and product design documentation deliverables to… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …required Experience in an FDA regulated Class III electrical medical device manufacturing environment preferred. preferred and Experienced in process ... to understand the appropriate legal and regulatory requirements in the areas of medical device operations and to establish robust processes and controls to… more
- Philips (Bothell, WA)
- …if: You have a minimum of 8+ years' Regulatory Affairs experience within FDA regulated Medical Device /HealthTech product environments. Experience with ... Software as Medical Device (SaMD) and Ultrasound Imaging Devices highly desired. You have strong knowledge of US FDA , China NMPA, CE Marking, EU MDD/MDR,… more
- Sotera Health Services, LLC (Grand Prairie, TX)
- …of regulatory affairs for FDA (or international equivalent) registered medical device or pharmaceutical manufacturer and direct experience with conducting ... six (6) years' experience in the pharmaceutical, food or medical device industry with GMP/GLP knowledge a...50% annually. Must possess a thorough understanding of US FDA Quality Systems Regulations, ISO 9000 regulations,… more
- SkyElia (Paramus, NJ)
- …preferred. M&A integration experience highly desired. 2+ years of experience in the medical device industry. 2+ years of experience in a project management ... About the job Project Manager, Medical Devices The Project Lead is responsible for...recommend program improvements to senior leaders. Execute program plans ( quality , risk, communication, staffing, etc.) and capture and communicate… more
