- Medtronic (Northridge, CA)
- …Systems globally. This role supports quality management systems (QMS) to ensure compliance with FDA , ISO, and other applicable standards. This role is ... innovation in a more connected, compassionate world. **A Day in the Life** The Quality Systems Business Analyst will be working across the Diabetes Quality … more
- Medtronic (Northridge, CA)
- …meaningful innovations. The Sr Program Manager - Development Process & Compliance will be responsible to lead/co-lead the Product Development processes encompassing ... on navigating through product development activities through the product lifecycle ensuring compliance with regulations and standards. + This role is critical to… more
- Envista Holdings Corporation (Pomona, CA)
- …QUALIFICATIONS:** + Experience with statistical software (Minitab, JMP, etc.) + Certified Quality Engineer preferred. + FDA Quality System Regulation ... claims and target markets early in the product development lifecycle. + Performs quality engineering reviews of design documentation for compliance with stated… more
- Stryker (San Jose, CA)
- …software design, development, and validation strategies, ensuring documentation aligns with Quality Management Systems compliance requirements. + Partner with ... **Stryker** is hiring a **Staff Software Quality Engineer, Design Assurance** to support our Medical's...by implementing software industry best practices and regulatory standards ( FDA , TGA, EUMDR, IT). + Engage in design and… more
- Danaher Corporation (Sunnyvale, CA)
- …assessment to identify and implement improvements. This position reports to the Senior Manager Quality Systems - Compliance and is part of the Quality ... compliance with local, state, and federal regulations and standards including compliance with Food & Drug Administration ( FDA ), ISO 13485, European Union… more
- Abbott (Alameda, CA)
- …Our 114,000 colleagues serve people in more than 160 countries. **Sr. Specialist Quality Assurance** **Working at Abbott** At Abbott, you can do work that matters, ... female executives, and scientists. **What You'll Work On** The Sr. Specialist Quality Assurance will be responsible for training, oversight and measuring performance… more
- Astrix Technology (Irvine, CA)
- …teams ( Quality , Manufacturing, R&D, Supply Chain, Finance, etc.). + Ensure compliance with the company's Quality System policies and procedures and ... reports, etc.) + Familiarity with medical device complaint files and quality records + Knowledgeable of FDA regulations, 21 CFR part 820 and Part 803 and ISO… more
- Astrix Technology (Irvine, CA)
- …teams to drive product and process improvements + Maintain compliance with FDA , ISO 13485, and global quality standards + Assist with manufacturing line ... ** Quality Operations Specialist** Engineering Irvine, CA, US Pay...+ Proficient in Microsoft Excel **Preferred:** + Knowledge of FDA regulations (21 CFR 820/803), ISO 13485 + Experience… more
- ThermoFisher Scientific (San Francisco, CA)
- …**Knowledge,** **Skills** **and Abilities:** + Exceptional cGMP, GLP and FDA compliance knowledge. + Possess a highly developed quality , regulatory and ... Systems aligning with Regulatory and Corporate Standards. Guide team to foster quality culture, compliance , and improvement. Lead team responsible for Document… more
- Oura (San Francisco, CA)
- …product development, approval, and lifecycle management for all regulated features. + Ensure compliance with FDA , CE (MDR), and other relevant global regulatory ... We are looking for a Director, Regulatory Affairs and Quality Assurance to play a key role in shaping...wearables strongly preferred. + Proven track record of successful FDA submissions (510(k), De Novo) and international regulatory approvals.… more