- Cepheid (Miami, FL)
- …about the Danaher Business System which makes everything possible.The Sr. Quality Specialist is responsible for supporting quality systems activities ... design control and risk management activities in accordance with FDA and ISO regulations. This position is also responsible...shelf-life.This position is part of the Product Life Cycle Quality & Stability team. It will be in Sunnyvale,… more
- Cepheid (Miami, FL)
- …about the Danaher Business System which makes everything possible.The Senior Quality Systems Specialist is responsible for functioning as Lead Internal Auditor ... to schedule, plan, perform, and document internal audits of Cepheid's Quality Management System (QMS), providing continuous and rigorous assessment to identify and… more
- Beckman Coulter Diagnostics (Miami, FL)
- …diagnostic tools that address the world's biggest health challenges. The Global Supplier Quality Engineer - Metals for Beckman Coulter Diagnostics will serve as a ... critical quality liaison between Beckman Coulter and our key metals...be a plus if you also possess:Experience working in FDA -regulated industries or medical device manufacturing environments.Professional certifications such… more
- Aldevron (Miami, FL)
- …solutions that safeguard and improve human health.This position is part of the Quality and Regulatory Affairs Department located in Fargo, North Dakota and will be ... validation with minimal assistance.Collaborate with Analytical Method Development and Quality Control (QC) Laboratory Associates to support the implementation of… more
- Pall (Miami, FL)
- …Pall is there, helping protect critical operating assets, improve product quality , minimize emissions and waste, and safeguard health. For the exponentially ... the Danaher Business System which makes everything possible.Director Global Quality and Regulatory ComplianceJOB SUMMARYInterprets federal/state/international regulations as they… more
- Sanofi Group (Framingham, MA)
- …Global Quality . . **Core member of critical governance** + Sanofi's GMP GDP Quality Council to facilitate sharing of US FDA inspection findings and best ... Advocacy Leadership Team + **Lead cGMP compliance projects** aligned with the company's Quality Operations strategy and US FDA regulations. + **Drive digital… more
- Abbott (Sylmar, CA)
- …Gage R&R, calibration, test methods, and NCMR dispositioning. + Knowledge of Quality Systems, FDA regulations, ISO 13485 and applicable worldwide regulatory ... position is responsible for assisting engineers in developing and maintaining quality engineering methodologies and providing quality technical support within… more
- Stryker (San Jose, CA)
- … quality . + Lead service audits (internal and external, including Corporate and ISO/ FDA ) and monitor key quality metrics to drive continuous improvements. + ... + Knowledge of applicable domestic and international regulations and quality system standards - FDA QSR, MDD,...international regulations and quality system standards - FDA QSR, MDD, ISO3485, ISO9001, etc. Health benefits include:… more
- Abbott (Alameda, CA)
- …+ Ensures internal activities and external partnership activities meet applicable regulations and quality standards including FDA QSR and ISO 9001/ ISO 13485 + ... Ensures external partnership activities meet applicable regulations and quality standards including FDA QSR and ISO 9001/ ISO 13485. + Assists in the evaluation,… more
- Caris Life Sciences (Phoenix, AZ)
- …and/or diagnostic/ FDA /IVD labs is a plus. + Knowledge of ISO 13485 and ISO 14971, FDA Quality System Regulation 21 CFR Part 820 or cGMP is a plus. + ... Experience in supporting FDA inspections as a quality SME and an ability to interpret regulatory requirements. + Working knowledge of CAPA process and change… more
- Caldera Medical (Westlake Village, CA)
- …Provides a key role in assuring organizational compliance with the defined Caldera Medical quality system, FDA QSR/GMP regulations, ISO 13485 quality system ... Quality Engineer - Westlake Village, 100% ONSITE Caldera Medical's Mission - To Improve the Quality of Life for Women! Message from the Hiring Manager: The … more
- Abbott (Santa Clara, CA)
- …with all levels of employees, customers, contractors, and vendors. + Knowledge of Quality Systems, FDA regulations, ISO 13485 and applicable worldwide regulator ... Our business purpose is to restore health and improve quality of life through the design and provision of...Heart Division of Abbott, reporting to the Manager of Quality . + Conduct functional testing as required by component… more
- Catalent Pharma Solutions (Harmans, MD)
- …and establishing validation policies and strategies that align with Catalent's quality standards, FDA /EMA requirements, and industry best practices. This ... of life-enhancing and life-saving treatments for patients annually. Our FDA -licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located… more
- Medtronic (Lafayette, CO)
- …AND OTHER DUTIES MAY BE ASSIGNED:** + Mastering knowledge of applicable Quality , FDA (Food & Drug Administration) Medical Device Directives/ Regulation, ... System schema or standard. + Demonstrated knowledge of all quality system elements and regulatory requirements (ie FDA... quality system elements and regulatory requirements (ie FDA , GMP, QSR and ISO 13485, and MDSAP) for… more
- Envista Holdings Corporation (Pomona, CA)
- …QUALIFICATIONS:** + Experience with statistical software (Minitab, JMP, etc.) + Certified Quality Engineer preferred. + FDA Quality System Regulation ... **Job Description:** The **Sr. Quality Engineer** plans and conducts activities concerned with...and process changes. + Maintains a working knowledge of FDA GMP, ISO 13485 standards and other applicable standards.… more
- Kelly Services (Sacramento, CA)
- …pharmaceutical products. This includes ensuring compliance with cGMP regulations, internal quality standards, and applicable regulatory requirements (eg, FDA , ... industry is essential. + Knowledge of cGMPs, Production Processes, Quality Systems, and FDA regulations + Knowledge of current Good Manufacturing Practices and… more
- DEKA Research & Development (Manchester, NH)
- …Writing experience + Excel, Word, Visio skills Nice skills to have: + Knowledge of FDA 's Quality System Regulation + Knowledge of ISO 13485 and related standards ... at DEKA and be at the forefront of driving quality excellence! As our Junior Quality Engineer,...determine the best approach and provide guidance on QMS, FDA Part 820, and ISO 13485 compliance to design… more
- Curia (Hopkinton, MA)
- …for the compilation of Curia documentation, systems and controls to ensure inspection-ready quality systems (ISO, FDA , QP, EMEA) for domestic and international ... SUPERVISOR, QUALITY ASSURANCE in Hopkinton, MA Build your future...with the ability to resolve conflict + Knowledge in FDA , cGMPs (21 CFR, 210/211, 820, and 600); ISO… more
- Abbott (Alameda, CA)
- …**Preferred Qualifications** + Prior medical device experience preferred. + Detailed knowledge of FDA Quality System Regulations (21 CFR Part 820), GMP, and ISO ... Our 114,000 colleagues serve people in more than 160 countries. **Senior CAPA Quality Engineer** **Working at Abbott** At Abbott, you can do work that matters,… 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
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