- BD (Becton, Dickinson and Company) (San Diego, CA)
- …them in a large-scale and rapidly evolving business. + Provide operations and quality leadership during FDA and notified body site inspections. + Interface ... 14971), and ISO/EC (MDD/MDR, IVDD/IVDR, MDSAP, CMDR, ISO 13485, J-PAL) requirements, Quality Assurance/Control, Statistical analysis, and FDA QSR's (21 CFR Part… more
- Hologic (San Diego, CA)
- …the company's quality system activities and design comply with the FDA 's Quality System Regulations (QSRs), ISO 13485, and applicable state requirements. ... environment, ideally in the IVD space. + Working knowledge of Quality Management System for Medical Device Manufacturing FDA 21 CFR 820, ISO 13485 as well as CE… 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, ISO3485, ISO9001, etc. $130,700.00 - $173,000.00 -… 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
- Abbott (Santa Clara, CA)
- …with all levels of employees, customers, contractors, and vendors. + Knowledge of Quality Systems, FDA regulations, ISO 13485 and applicable worldwide regulatory ... Our business purpose is to restore health and improve quality of life by designing and providing device and...+ Recommend improvements to the production process to ensure quality control. + Responsible for completing documentation in a… 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
- 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
- Kelly Services (Sacramento, CA)
- …within Pharmaceutical or GMP-regulated environment. + Knowledge of cGMPs, Production Processes, Quality Systems, and FDA regulations + Proficiency in handling of ... ** Quality Management System (QMS) Lead** Kelly(R) Science &...role, you'll be responsible for managing and maintaining the Quality Management System (QMS), coordinating audits, analyzing quality… more