• Director, FDA Submissions

    MD Anderson Cancer Center (Houston, TX)
    …and the public. This position will be responsible for the regulatory and quality oversight of MD Anderson's FDA regulated investigational products and ... regulatory specialists responsible for advising MD Anderson's investigators on FDA submission requirements and pathways, develop investigational plans and protocols,… more
    MD Anderson Cancer Center (10/10/24)
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  • Senior Quality Assurance Analyst, Cell…

    Mayo Clinic (Jacksonville, FL)
    …and inclusion, and provides the resources you need to succeed. **Responsibilities** The Sr. Quality Analyst, FDA Regulated Manufacturing will be part of a team ... related field is preferred or a bachelor's degree, 5 years' experience supporting FDA regulated product manufacturing, and 5 years quality , regulatory, or… more
    Mayo Clinic (11/14/24)
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  • Sr. QMS Specialist - Hybrid

    Envista Holdings Corporation (Pomona, CA)
    …in compliance with regulatory requirements and corporate standards. This involves assuring quality standards ( FDA , ISO, CMDCAS, MDD, MDR, MDSAP and Canadian ... Quality Management + 3-5 years experience working with an FDA (QSR) and ISO Quality System **PHYSICAL DEMANDS:** The physical demands described here are… more
    Envista Holdings Corporation (10/31/24)
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  • Quality Technician

    TreeHouse Foods, Inc. (Lancaster, PA)
    …occupational safety (OSHA), building and electrical codes, and food safety and food quality ( FDA ) in addition to environmental safety (EPA) in accordance with ... **Employee Type:** Full time **Location:** PA Lancaster **Job Type:** Quality Assurance **Job Posting Title:** Quality Technician **About Us:** TreeHouse Foods… more
    TreeHouse Foods, Inc. (11/22/24)
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  • FDA Regulatory Affairs Manager…

    Vanderbilt University Medical Center (Nashville, TN)
    …. The VUMC Laboratory Quality Management Department is in need of an FDA Regulatory Affairs Manager to join the team! **This position is eligible for a $10,000 ... Administration **Job Summary:** Leads VML's responses to the recent FDA LDT regulations. Develops a team to support our...goals and objectives. Continuously demonstrates a strong focus on quality in spite of time and other pressures. Anticipates… more
    Vanderbilt University Medical Center (11/25/24)
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  • Supplier Quality Assurance Manager

    Abbott (Des Plaines, IL)
    …education and work experience + Minimum **5 years Related to supplied product quality within an FDA /ISO certified environment.** + Multi-tasks, prioritizes and ... Plaines, IL** location (in office daily) in the Abbott Molecular Diagnostics, Quality Assurance Group. Abbott Molecular is a leader in molecular diagnostics and… more
    Abbott (10/09/24)
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  • Lead Software Quality Engineer

    Abbott (Kansas City, MO)
    …and Data Integrity (ALCOA+) principles. + Knowledge of FDA 21 CFR part 820 (US FDA Quality Systems Regulation), 21 CFR part 11, GMP, IEEE 1012, IEC 62304 and ... + Demonstrates commitment to the development, implementation and effectiveness of Abbott Quality Management System per ISO, FDA , and other regulatory agencies.… more
    Abbott (10/01/24)
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  • Quality Control Supervisor

    Bristol Myers Squibb (Indianapolis, IN)
    …with RSO and QA to ensure compliance with GMP regulations, safety guidelines, and quality standards ( FDA , USP, NRC, EP, and other regulatory agencies as needed). ... the global leader in radiopharmaceuticals. RayzeBio is seeking a Quality Control Supervisor, reporting to the Sr. Manager of... Control Supervisor, reporting to the Sr. Manager of Quality Control. The position will oversee quality more
    Bristol Myers Squibb (11/24/24)
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  • Principal Quality Systems Specialist

    Medtronic (Santa Rosa, CA)
    …processes, and documentation to assure compliance with Medtronic internal policies and quality system processes, FDA regulations, ISO 13485, Medical Device ... body's largest artery, the aorta In this exciting role as a **Principal Quality Systems Compliance Specialist** you will have responsibility for compliance to … more
    Medtronic (11/25/24)
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  • Head of Quality , Ultrasound

    Philips (Bothell, WA)
    …Act as the management representative for all key regulatory agencies for product safety and quality (eg: US FDA , EU MDR, TGA, MHLW, NMPA, etc.). Develop and ... **Head of Quality , Ultrasound** Lead and execute the Quality...maintain an effective working relationship with US FDA and other international regulatory bodies. + Proactively ensure… more
    Philips (11/01/24)
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  • Manager, Product Quality Waterpik

    Church & Dwight Co., Inc. (Fort Collins, CO)
    …in Fort Collins, CO leads the Water Pik organization to achieve compliance to the FDA Quality System Regulation (QSR), ISO 13485, MDSAP and/or other quality ... system procedures. Leads in procedure development eg ISO, FDA , MDSAP, when required. Ensures product quality ...ISO, FDA , MDSAP, when required. Ensures product quality and takes appropriate action when non-conformances are identified.… more
    Church & Dwight Co., Inc. (10/11/24)
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  • Quality Control Technician

    Actalent (Santa Ana, CA)
    …field or comparable additional experience. + Associate degree with 2 years of FDA quality experience is acceptable. + Pharmaceutical experience in an aseptic ... Job Title: Quality Control TechnicianJob Description We are looking for...experience (2 years). + Aseptic technique. + Experience with FDA regulations (2 years). + Laboratory skills. + Batch… more
    Actalent (11/23/24)
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  • Quality Control Technician

    ManpowerGroup (St. Paul, MN)
    …levels of employees, customers, contractors, and vendors. * Working knowledge of Quality Systems, FDA regulations, ISO 13485 and applicable worldwide regulator ... **Job Title:** Quality Control Technician **Location:** Saint Paul, MN 55117...months with possibility of extension or conversion. **Overview:** As Quality Assurance Technician, you will support manufacturing in the… more
    ManpowerGroup (11/23/24)
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  • Senior Design Quality Engineer (Software)…

    Stryker (San Jose, CA)
    …needs. + Conduct Product and Cybersecurity Risk Assessments by working with current product quality data, FDA MAUDE database, and other sources to find issues ... to learn more:US Stryker employee benefits. (https://d25zu39ynyitwy.cloudfront.net/oms/000000/document/2024/6/SMVZW\_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf) **Senior Design Quality Engineer - Software (Hybrid)** **Stryker** is hiring a… more
    Stryker (10/06/24)
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  • Quality Lead, US Consumer Healthcare

    Sanofi Group (Morristown, NJ)
    …US Country Quality Head's direction **_About You_** + 10+ years' Quality experience within FDA regulated environment. Consumer Healthcare or Pharma industry ... ** Quality Lead, US Consumer Healthcare** Location: Morristown, NJ...key colleague in regulatory inspections in Morristown, NJ (ex. FDA & DEA) related to GxP processes and provide… more
    Sanofi Group (11/20/24)
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  • Manager, Quality System Training

    Terumo Medical Corporation (Elkton, MD)
    …and enterprise/corporate business requirements. As a minimum, this includes the FDA 's Quality System Regulation/Current Good Manufacturing Practices (21 CFR ... Manager, Quality System Training Date: Nov 14, 2024 Req...FDA , ISO 13485, EU MDR, MDSAP and global quality system requirements for medical devices. + Ability to… more
    Terumo Medical Corporation (11/15/24)
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  • Senior Quality Engineer

    Medtronic (Northridge, CA)
    …device or related industry + Experience with FDA 21 CFR Part 820 FDA Quality System Regulation, MDSAP, ISO 14971 risk management and/or other relevant ... commercialized products and projects? Are you a senior level Quality Engineer with experience providing technical and quality... Quality Engineer with experience providing technical and quality systems expertise? If so, you'll be an awesome… more
    Medtronic (11/06/24)
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  • Medical Devices Software Quality Engineer

    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 ... throughout the software development lifecycle, including familiarity with SDLC processes and Quality Management Systems (QMS) compliant with US FDA regulations… more
    US Tech Solutions (10/18/24)
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  • Principle Quality Engineer

    Mallinckrodt Pharmaceuticals (Webster Groves, MO)
    …10-15 yrs experience in manufacturing and control of pharmaceutical manufacturing and/or Quality with extensive FDA and global regulatory experience. Preferred ... Job Title Principle Quality Engineer Requisition JR000014528 Principle Quality ...compliance audits and respond to audit observations. Support with FDA and other regulatory agencies investigations, inspections, and inquiries… more
    Mallinckrodt Pharmaceuticals (09/26/24)
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  • Quality Assurance Operations Lead

    Cambrex High Point (Charles City, IA)
    …in this section may be assigned. + Qualifications/Skills + Working knowledge of quality systems, cGMP, FDA requirements and industry standards + Strong critical ... manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career...All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the… more
    Cambrex High Point (11/25/24)
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