- Caris Life Sciences (Irving, TX)
- …in accordance with internal SOPs, Quality System Requirements which include ISO 13485, FDA QSR , IVDR, SOX, SOC2, and IEC 62304 + Reviews and approves various Design ... applicable Software Validation Planning documents in alignment with FDA QSR , 21 CFR Part 11, and GAMP5 regulation requirements....SDLC process and the application of ISO 13485, FDA QSR , 21 CFR Part 11, IEC 62304, GAMP5, SOX,… more
- Cordis (Miami Lakes, FL)
- …Regulatory & Systemic Expertise + Apply in-depth knowledge of ISO?13485, FDA QSR , and global regulatory expectations to guide supplier compliance. + Conduct supplier ... manufacturing environments. **Preferred Qualifications** - Strong understanding of ISO?13485, FDA QSR , supplier audits, and global QMS standards. - Lean Six Sigma… more
- Teleflex (Pleasanton, CA)
- …- Familiarity with ISO 13485, ISO 62304, ISO 14971, IEC 82304-1, MDD, and FDA QSR . - Experience developing mechatronic products with IEC 60601 is a plus. - Medical ... for performing all duties in compliance with FDA's Quality System Regulation ( QSR ), ISO13485, the Canadian Medical Device Regulations, and all other international… more
- Battelle Memorial Institute (Columbus, OH)
- …interaction with suppliers + Understanding of the FDA's Quality System Regulation ( QSR ) + Experience with structured testing of devices or components + Involvement ... in an ISO 13485 or ISO 9001 quality environment, and experience with structured methodologies and processes for the conduct of product development **Benefits: Live an Extraordinary Life** We care about your well-being, not just on the job. Battelle offers… more
- Cordis (Irvine, CA)
- …of validation verification process, Gage R&R, and a clear understanding of FDA's QSR and GMP + Basic proficiency in SolidWorks and computer-aided design a plus ... + Strong analytical, problem solving, and project management skills + Fluent in English + Ability to safely and successfully perform the essential job functions consistent with the ADA, FMLA, and other federal, state, and local standards, including meeting… more
- Cordis (Irvine, CA)
- …of Validation/Verification process, Gage R&R, and a clear understanding of FDA's QSR and GMP + Strong analytical, problem solving, and project management skills ... + Fluent in English **Working Hours** + Third shift production: 10:30 PM to 6:00 AM (with 30 min break) + Candidates must be available to work on first or second shift for a training period prior to starting on the third shift **Pay / Compensation** The… more
- Cordis (Irvine, CA)
- …Material Reports) and CAPA (Corrective Action, Preventative Action) + Champion cGMP and QSR concepts and procedures + Champion 5S and Lean Manufacturing principles + ... Lead and manage projects (as assigned). Develop resources to accomplish tasks and manage timelines to meet project goals + Develop training programs for new Manufacturing Teammates and coordinate training to revisions/new releases of documentation + Update… more
- Olympus Corporation of the Americas (Westborough, MA)
- …for Industry and Food and Drug Administration Staff', Quality System Regulation ( QSR ), ISO 13485, 14971, EN 60601, Council Directive 93/42/EEC, 62366. HE 75, ... AAMI. + Experience on multiple projects with high-demand schedules and with complex, multi-functional development projects and cross-disciplinary teams. + Experience leading a team of HFEs. + Experience working directly with users to develop and evaluate new… more
- GRAIL (Durham, NC)
- …and understanding of applicable regulations and standards, including but not limited to QSR , ISO 13485, CAP/CLIA, NYSDOH, ISO 15189, IVDR. + Experience using an eQMS ... required; Veeva Vault preferred. + Proven ability to efficiently manage workload under tight deadlines and pressure in a composed manner. + Demonstrated ability to perform meticulous work with a high degree of accuracy and completeness. + Experience supporting… more
- Integra LifeSciences (Mansfield, MA)
- …MDD (Medical Device Directive), IEC 62366, ISO 13485 (Quality Management Systems), FDA QSR and cGMP. * Strong analytical skills and a working knowledge of ... problem-solving methodologies * Working knowledge of DFSS techniques * 8 years of experience in a Quality Assurance role for medical device or pharmaceutical product development * Fluent in French and English * Knowledge of industry best practices and advances… more
- Integra LifeSciences (Princeton, NJ)
- …resources. + Ensure that all projects are in compliance with cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements. + Support and address ... comments and suggestions associated with sterilization and microbiological test method validations and monitoring procedures. + Change control, non-conformance and CAPA support. + Support management with providing direction to the team, coordinating workflow,… more
- Teleflex (Chelmsford, MA)
- …supporting manufacturing, preferably medical devices. - Experience with FDA QSR process and validation documentation requirements a plus. **Specialized Skills ... / Other Requirements** - Experience with IQ/OQ/PQ and P/DFMEA - Experience with Injection molding equipment and processes (especially in Medical Devices) - Experience with Resins and other Polymers used in Injection Molding - Experience with Tooling used in… more
- Kerry (Beloit, WI)
- …leadership, and product development across customer segments including retail, QSR , foodservice, and industrial manufacturing. The Director will be responsible ... for shaping the future of authentic, clean label, and functional stocks and broths, partnering closely with cross-functional stakeholders to deliver value through science-backed, culinary-inspired solutions. This is a high-impact leadership role that combines… more
- Cordis (Irvine, CA)
- …of validation verification process, Gage R&R, and a clear understanding of FDA's QSR and GMP - Basic proficiency in SolidWorks and computer-aided design a plus ... - Strong analytical, problem solving, and project management skills - Fluent in English - Ability to safely and successfully perform the essential job functions consistent with the ADA, FMLA, and other federal, state, and local standards, including meeting… more
- Cordis (Miami Lakes, FL)
- …validation (IQ/OQ/PQ) activities, ensuring compliance with ISO 13485 and FDA QSR requirements. + Troubleshoot and resolve extrusion process issues, ensuring ... manufacturing and compliance to ISO 13485 and FDA 21 CFR Part 11/ QSR . + Proficiency with statistical analysis tools and process validation methodologies. **Skills… more
- Teleflex (Plymouth, MN)
- …locations and project teams. - Familiar with FDA documentation requirements, QSR requirements for medical devices, Lean Manufacturing and Good Manufacturing ... Practices. - Experience with Microsoft Word/Excel is required. Experience with Solidworks, Microsoft Project and MiniTab is preferred. - Working knowledge of GD&T with proficiency in SolidWorks or equivalent CAD software. - Excellent oral and written… more
- Battelle Memorial Institute (Columbus, OH)
- …plastic part experience + Understanding of the FDA Quality System Regulation ( QSR ) and involvement in an ISO13485 operational environment **Travel Requirements:** up ... to 10% **Benefits: Live an Extraordinary Life** We care about your well-being, not just on the job. Battelle offers comprehensive and competitive benefits to help you live your best life. + **Balance life through a compressed work schedule** : Most of our team… more
- Zebra Technologies (Columbus, OH)
- …closing sales opportunities for customers in the Hospitality vertical, specifically in QSR (Quick Serve Restaurant) and FCD (Fine Casual Dining). This position ... submitted clearly showcase experience in hospitality and/or selling to customers in QSR (Quick Serve Restaurant) and/or FCD (Fine Casual Dining). This remote role… more
- TravelCenters of America (Burns, WY)
- …TravelCenters of America offers a convenient, one-stop shopping experience to our customers. Each location has a plethora of dining options which gives our guests the ... There's never been a better time to join TravelCenters of America! For more than 50 years, millions of professional truck drivers and motorists have called our travel centers home, depending on us daily for fuel, food, truck maintenance and essential services.… more
- TravelCenters of America (Portage, WI)
- …TravelCenters of America offers a convenient, one-stop shopping experience to our customers. Each location has a plethora of dining options which gives our guests the ... There's never been a better time to join TravelCenters of America! For more than 50 years, millions of professional truck drivers and motorists have called our travel centers home, depending on us daily for fuel, food, truck maintenance and essential services.… more
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