- 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
- Kelly Services (Lodi, CA)
- …consideration, please apply. Kelly(R) Science & Clinical is seeking a Quality Assurance Specialist I for temporary position (with potential to extend/convert) ... Hiring Experts. **Pay Rate:** Night Shift: $29.37/Hour (non-negotiable) **Overview:** The Quality Assurance Specialist is responsible for reviewing records to comply… more
- Stryker (Portage, MI)
- …customer input to improve safety and effectiveness. + Monitor compliance with Medical Quality Procedures, FDA , and other global health regulations, and assist ... more:US Stryker employee benefits. (https://d25zu39ynyitwy.cloudfront.net/oms/000000/document/2024/6/SMVZW\_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf) Stryker is hiring a ** Quality Assurance Engineer (Hybrid)** , in **Portage, MI** to… more
- Actalent (Hartland, WI)
- …and batch record information. + Ensure production personnel follow GMP's, SOP's, FDA regulations, and quality processes. Essential Skills + Quality ... with production. + Strong verbal communication skills. + Experience with quality inspection, quality auditing, FDA inspections, and GMP. Additional Skills &… more
- 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
- 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
- Texas State University (San Marcos, TX)
- …inspection operations + Conducts ongoing technical assistance and performance monitoring of FDA Inspectors for programmatic quality assurance + Assists Program ... the nation. The Program Coordinator will work closely with the Program Manager ( FDA State Program Coordinator) to coordinate and provide oversight to the Food and… more
- 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 (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
- Actalent (Santa Ana, CA)
- …or comparable additional experience (Associates degree acceptable with 2 years of FDA quality experience). Additional Skills & Qualifications + Pharmaceutical ... quality control within an aseptic fill operation and experience with FDA /cGMP standards. Responsibilities + Conduct quality control inspections and tests. +… more
- 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
- 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
- Medtronic (Los Angeles, CA)
- …development projects and changes to existing products are conducted in compliance with FDA Quality System Regulations, EU MDR and in-house Standards. + ... insulin delivery + Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive + Proficiency… more
- 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
- 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
- LSI Solutions (Victor, NY)
- …+ Excellent attention to detail and strong follow-up skills. + Knowledgeable on FDA Quality System Regulation and proficient with related submissions for device ... to Domestic Regulatory Projects will 1) prepare regulatory submissions, including FDA Q-Submissions, 513(g) Submissions, 510(k) Submissions, and De Novo Requests as… more
- Teleflex (Olive Branch, MS)
- …medical device regulations, standards, and guidance documents. Including: o 21 CFR 820 US FDA Quality System Regulations. o ISO 13485 Medical devices - ... Quality Supervisor **Date:** Oct 25, 2024 **Location:** Olive...Corrective Action / Preventative Actions (CAPA). * Participates in FDA inspections, ISO certifications, surveillance audits, etc. * Manages… more
- 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
- Abbott (Plano, TX)
- …skills.Ability to prioritize. Ability to multitask. **Preferred Qualifications** + Knowledge of FDA Quality System Requirements and other applicable US Code of ... mothers, female executives, and scientists. **The Opportunity** We are seeking a Quality Engineer for our Plano, TX location in the Neuromodulation Division. Our… more
- 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