- Cepheid (Miami, FL)
- …field.Related work experience in Quality with a focus on assay development in a medical device or IVD l industry with applicable knowledge of FDA QSR, ... about the Danaher Business System which makes everything possible.The Sr. Quality Specialist is responsible for supporting quality systems activities… more
- Cepheid (Miami, FL)
- …(IVDR) as well as other applicable global regulatory requirements, including Medical Device Single Audit Program (MDSAP) participating regulatory authorities ... about the Danaher Business System which makes everything possible.The Senior Quality Systems Specialist is responsible for functioning as Lead Internal Auditor… more
- Beckman Coulter Diagnostics (Miami, FL)
- …needs.It would be a plus if you also possess:Experience working in FDA -regulated industries or medical device manufacturing environments.Professional ... diagnostic tools that address the world's biggest health challenges. The Global Supplier Quality Engineer - Metals for Beckman Coulter Diagnostics will serve as a… more
- ManpowerGroup (Medina, NY)
- …CAPA, Product Improvement Teams). **What's Needed?** + Strong knowledge of the FDA Quality System and Medical Device Reporting regulations (21 CFR 803, ... Our client, a leader in the medical device industry, is seeking a...Complaint Management Specialist, you will be part of the Quality Assurance department supporting the Product Surveillance team. The… more
- J&J Family of Companies (Albany, NY)
- …moral character while professionally representing the company. + Comply with all corporate compliance, FDA , medical device , quality standards and ethics. ... multiple priorities. + Must not be debarred by FDA for work in any Medical Device business. + Must have a valid driver's license. + Operate as a team and/or… more
- Cedars-Sinai (Los Angeles, CA)
- …years of experience using 3D model software preferred + Knowledge of FDA Quality System Regulations, Medical Device Directives including ISO 13485, ISO ... and full end-to-end integration tests, when it applies; Supports quality insurance effort to gain user acceptance. 4. Delivery:...Team** Cedars-Sinai is one of the largest nonprofit academic medical centers in the US, with 886 licensed beds,… more
- Sanofi Group (Framingham, MA)
- …years) with a minimum of 15 years relevant experience in the pharmaceutical, biotech, medical device , or related industries. + Extensive knowledge of Quality ... **Core member of critical governance** + Sanofi's GMP GDP Quality Council to facilitate sharing of US FDA... Quality Council to facilitate sharing of US FDA inspection findings and best practices across entities, M&S… more
- Hologic (Newark, DE)
- …to commercialization. + **Regulatory Standards:** Familiarity with ISO and FDA quality systems regulations and medical device design and development ... Experience:** + Experienced with ISO and FDA quality systems regulations. + Prior experience in medical... quality systems regulations. + Prior experience in medical device design and development cycles. +… more
- Integra LifeSciences (Plainsboro, NJ)
- …treatment pathways to advance patient outcomes and set new standards of care. The **Sr.** ** Quality Engineer - Medical Device / Pharma** will provide Plant ... Administration ( FDA ) regulations, ISO 9001, ISO 13485:2003, Medical Device Directive (MOD), the Canadian ...Experience: 6 to 8 years of experience in a Quality Assurance role for medical device… more
- Kelly Services (Irvine, CA)
- **Now Hiring: Quality Control Inspector - Medical Device Manufacturing** **Location:** Irvine, CA | **Pay:** $28-$32/hour (DOE) **Schedule:** Monday-Friday, ... Minimum of 1 year of quality inspection experience, preferably within the medical device industry or other regulated environments. + Familiarity with MS… more
- Wolters Kluwer (Chicago, IL)
- …to the medical device industry eg, ISO, QSR, GMP. Must have EU MDR and FDA Class II medical device experience, focused on software as a medical ... on-market medical devices including Software as a Medical Device (SaMD) within the Health Division...Quality System Regulation for SaMD regulated by the FDA , and EU MDR. + Perform design control activities… more
- Pentax Medical (Redwood City, CA)
- … Medical provides endoscopic imaging devices and solutions to the global medical community. Position Opening: Medical Device Assembler- Catheter Why ... JOIN Us? We are an established medical device leader that is preparing for...office (ie Word, Excel). . Previous experience working in quality management systems, functioning within FDA regulations.… more
- Sanofi Group (Cambridge, MA)
- …to search deeper and solve sooner than ever before. Our team has released an FDA certified class II medical device titration application. We are gearing ... quality assurance efforts for our Software as Medical Device (SaMD) products, ensuring that they...sciences. + 4+ years' experience in medical device product development (Design Control) focused on quality… more
- Astrix Technology (Fort Worth, TX)
- ** Quality Assurance Manager - Medical Device ** Quality Assurance Fort Worth, TX, US Pay Rate Low: 85000 | Pay Rate High: 90000 + Added - 04/06/2025 Apply ... a sharp professional that possesses these top 3 skills:** + Medical Device /Pharmaceutical industry experience + 4+ Years of Quality Assurance and CAPA… more
- US Tech Solutions (San Bruno, CA)
- …align with Quality System procedures, utilizing expertise in the medical device product development life-cycle, Risk Management, Design/Process Verification, ... NC/CAPA, Audits) and US and International Medical Device Regulations & Regulatory Agencies (eg, FDA ,... Manufacturing or Software as a Medical Device (SaMD). + Experience with Quality Management… more
- LSI Solutions (Victor, NY)
- …in 1986, located in beautiful Victor, New York, is a dynamic and growing medical device company with over 500 employees dedicated to advancing minimally invasive ... passionate people looking to make a difference in the medical device industry. By joining LSI SOLUTIONS(R)...Engineering for Medical Devices) + ISO 13485 ( Medical devices - Quality management systems) +… more
- LCI-Lawinger Consulting (Minneapolis, MN)
- …a critical role in ensuring the safety, effectiveness, and regulatory compliance of medical device products. Key Responsibilities: + Lead and support design ... (or equivalent experience). + 5+ years of experience in medical device design assurance, with a deep...device design assurance, with a deep understanding of FDA and ISO 13485 regulatory requirements. + Proven experience… more
- Pentax Medical (Montvale, NJ)
- …in effective communication with cross functional teams for better alignment Requirements of Medical Device , Senior Quality Engineer: + Bachelor's Degree or ... Manager, Production/Manufacturing Why JOIN Us? We are an established medical device leader that is preparing for...employee engagement + Exceptional attention to service, detail, and quality + Familiarity with PENTAX Medical products… more
- Takeda Pharmaceuticals (Lexington, MA)
- …degree with 15+ years of experience** + Minimum 5 years of combination product, medical device , or pharmaceutical industry experience + Experience with both ... control principles, while fostering collaboration across multidisciplinary teams to deliver device clinical outcomes that exceed quality benchmarks and… more
- West Pharmaceutical Services (Exton, PA)
- …+ 3-5 years (with Bachelor) or 2+ years (with Masters/PhD) of medical device regulatory experience + Experience with US FDA regulations (Title 21CFR820), EU ... Senior Specialist, Regulatory Affairs - Medical Device Requisition ID: 69746 Date:...for CE Marking. The Senior Specialist ensures timely and high- quality execution of all regulatory deliverables. In addition, the… more
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