- Abeona (Cleveland, OH)
- …team management or leadership experience. + Deep knowledge of cGMPS, ICH Q9 ( Quality Risk Management), FDA regulatory expectations. + General knowledge of ... leadership experience. + Deep knowledge of cGMPS, ICH Q9 ( Quality Risk Management), FDA regulatory expectations. +...of cGMPS, ICH Q9 ( Quality Risk Management), FDA regulatory expectations. + General knowledge of aseptic manufacturing… more
- Cardinal Health (Indianapolis, IN)
- …network across business and functional units to achieve positive outcomes. + Assists Quality Management with FDA and other regulatory agency activities. + ... **_What Quality Assurance contributes to Cardinal Health_** Quality...experience working with 21 CFR 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device) preferred +… 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
- 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
- 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
- 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
- AbbVie (Pleasanton, CA)
- …chemical, electrical), or other technical discipline. Must have 1 year of quality engineering work experience in FDA regulated medical device manufacturing ... mechanical drawings & GD&T + performing daily assigned tasks in compliance with FDA 's Quality System Regulation (QSR), ISO 13485, ISO 14971, MDR, & MDSAP; +… more
- Fresenius Medical Center (Lawrence, MA)
- …Understanding of Agile methodology desired but not required. . Thorough understanding of FDA Quality System regulations in relation to software development and ... and working remotely. **PURPOSE AND SCOPE** Act as a Quality Business Partner for Software as a Medical Device...as 21CFR 820.30, IEC62304:2016 amd.1, IEC81001-5-1, as well as FDA and MDCG guidance. . Responsible for the planning… more
- Integra LifeSciences (Braintree, MA)
- …2025. + Adequate knowledge of learning management software. + Experience in GMP and quality systems regulations ( FDA QSRs, ISO 13485:2016, CFR 820). + Proven ... what's possible and making headway to help improve outcomes. The Senior Quality Compliance Specialist -Training will create and conduct training programs to enhance… more