- Houston Methodist (Houston, TX)
- …customer service focus and application of positive language principles + Familiar with quality , compliance and FDA regulatory requirements for Good ... position will be responsible for assisting senior team members with aspects of compliance associated with the quality operations including but not limited to;… more
- System One (Durham, NC)
- Job Title: QA Consultant (GCP Compliance ) Location: Remote with potential travel to company sites as needed. Hours/Schedule: 20hrs/wk for first few months, then ... to assist a biotech company in preparing for an FDA audit with a strong focus on Good Clinical...with a strong focus on Good Clinical Practice (GCP) compliance . The ideal candidate will have a deep understanding… more
- Texas State University (San Marcos, TX)
- …for assistance and guidance from jurisdictions throughout the nation. The role of the FDA Tobacco Compliance Contract Specialist is to assist in the overall ... administration, coordination, training, and monitoring of the FDA Tobacco Compliance Check Program in Texas. The Contract Specialist creates and revises training… more
- 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
- 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 ... strong working relationship with the FDA . Effectively addresses and resolves FDA questions and concerns, ensuring compliance and alignment with Institutions… more
- BioBridge Global (San Antonio, TX)
- …within all Standard Operating Procedures (SOPs) and policies. Must maintain familiarity of regulatory/ quality compliance , to include FDA , EU, ISO, GHM, cGMP, ... clients to set Target Product Profile (TPP) and Critical Quality Attributes (CQA) for new products and services. Apply... Attributes (CQA) for new products and services. Apply Quality by Design (QbD) methodology and Design of Experiments… more
- BioFire Diagnostics, LLC. (Hazelwood, MO)
- …Deliverables. + Lead and support assessments of the quality systems for compliance (eg customers, FDA , ISO Registrars), and ensure that such assessments are ... Position Summary & Responsibilities: Support quality programs to develop, implement, and continually improve...implemented into the Company products and services. Support operations compliance with government regulations ( FDA , Canadian Medical… more
- Tecomet (Lansing, MI)
- …improve quality programs while reducing quality costs and maintaining compliance within FDA and ISO regulations. This is accomplished by utilizing ... ** Quality Assurance Manager** **JOB SUMMARY:** The Quality...+ ASQ, CQE, CQA, and/or CQM + Knowledge of ISO/ FDA Requirements **Working Conditions/Physical Abilities:** + Well lighted, heated/or… more
- Stryker (Redmond, WA)
- …testing, when required, to address post-market issues + Monitor compliance to Quality Procedures and FDA Quality System Regulations (QSR's) and update ... to learn more:US Stryker employee benefits. (https://d25zu39ynyitwy.cloudfront.net/oms/000000/document/2024/6/SMVZW\_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf) **Staff Post-Market Quality Engineer - Hybrid** Stryker is hiring a **Staff… more
- Tecomet (Warsaw, IN)
- …monitor and improve quality systems/programs, reduce quality costs and maintain compliance within FDA and ISO regulations for + $500 million in annual ... **TITLE** : Director Quality Assurance & Reg. Affairs Systems - Worldwide...compromise. + Assure Tecomet Medical is conducting business within compliance to the regulations, as cost effectively and efficiently… more
- Tecomet (Warsaw, IN)
- …monitor and improve quality systems/programs, reduce quality costs and maintain compliance within FDA and ISO regulations for + $40 million in annual ... **TITLE** : Quality Assurance and Regulatory Affairs Manager **Department:** ...without compromise. + Assure Tecomet is conducting business within compliance to the regulations, as cost effectively and efficiently… more
- Tecomet (Kenosha, WI)
- …monitor and improve quality systems/programs, reduce quality costs and maintain compliance within FDA and ISO regulations for + $40 million in annual ... + **Sr. Quality Assurance & Regulatory Affairs Manager** **POSITION SUMMARY**...without compromise. + Assure Tecomet is conducting business within compliance to the regulations, as cost effectively and efficiently… more
- Teva Pharmaceuticals (West Chester, PA)
- …validation experience in pharmaceutical industry; knowledge in validation and quality compliance (cGMP/cGLP/ICH/ FDA /USP/EU policies/guidelines) * Minimum ... projects o Responsible for completing projects to meet business needs with compliance against Teva procedures and regulatory requirements o Support all aspects of… more
- Church & Dwight Co., Inc. (Fort Collins, CO)
- …This position, based in Fort Collins, CO leads the Water Pik organization to achieve compliance to the FDA Quality System Regulation (QSR), ISO 13485, MDSAP ... to Win. Role Summary Reporting to the Senior Manager Quality & Compliance - Country Business &... system procedures. Leads in procedure development eg ISO, FDA , MDSAP, when required. Ensures product quality … more
- US Foods (Greensburg, PA)
- …production suspension to ensure food safety and quality continuity. Ensure regulatory compliance with USDA, FDA , State and local authorities and act as ... Community of Food People! Maintain, update, and implement national food safety and quality and regulatory compliance programs. Implements and maintains the GFSI… more
- System One (Mahwah, NJ)
- …of your work by maintaining compliance to all quality requirements. + Ensure compliance to all FDA and Worldwide Quality & Compliance regulations ... day operation including adjustment of workflow, test performance, and quality compliance . Under the direction of the...21CFR 610, 21CFR 1271, 21CFR11, EU Annex 1, cGMPs, FDA Guidance on Sterile Drugs Produced by Aseptic Processing… more
- Actalent (Allendale, NJ)
- …and maintain all quality documentation. Your role is critical in maintaining compliance with FDA and worldwide quality regulations, helping to ensure ... maintaining compliance with all quality requirements. + Ensure compliance with all FDA and worldwide quality and compliance regulations as… more
- System One (Mahwah, NJ)
- …of your work by maintaining compliance to all quality requirements. + Ensure compliance to all FDA and Worldwide Quality & Compliance regulations ... day-to-day activities including adjustment of workflow, test performance, and quality compliance . + Ensures compliance ...a supervisory or lead role. + Strong knowledge of FDA and EU regulatory standards. cGMP experience required. +… more
- Randstad US (Amityville, NY)
- …role is critical in maintaining the highest quality of our products, ensuring compliance with FDA , GMP, and HACCP standards. If you are interested please ... inspections of raw materials, in-process products, and finished goods to ensure compliance with food and pharmaceutical quality standards. + Process Monitoring:… more
- Abbott (Scarborough, ME)
- …development, implementation, improvement, and/or effectiveness of quality systems in compliance with applicable company, ** FDA , ISO, and other regulatory ... other duties & projects as assigned, with relation to compliance and Quality Systems. + Responsible for...to the medical device industry (ie 13485, MDSAP, IVDR, FDA QSR, 14971). In particular, 21 CFR Part 11… more