- Abbott (Livermore, CA)
- …the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000 ... you dream of. + Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO...and get on with their lives. This position provides regulatory compliance leadership for the business, ensuring the policies,… more
- Gilead Sciences, Inc. (La Verne, CA)
- …provides comprehensive support of these combination products. **Roles/Responsibilities:** + Monitor medical device standards for quality management system ... reports (MDRs) and provide documented justifications for reportable and non‑reportable regulatory decisions. + Support medical device and combination… more
- Abbott (Pleasanton, CA)
- …with cross-functional peers in quality , operation, marketing, clinical and regulatory , medical affairs, commercials to define an aligned and predictable ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… more
- Abbott (Alameda, CA)
- …and preventative action of medical devices , including software as a medical device (SaMD), in-vitro, diagnostic devices , consumer devices , and ... Device Master Record (DMR) are in compliance with regulatory standards and quality management policies and... devices or pharmaceutical products. + Knowledge of medical device standards including FDA QSR, ISO… more
- Abbott (Sylmar, CA)
- …a diverse and growing portfolio of digital health products, including software as a medical device (SaMD), connected devices , and digital health platforms. ... field (Master's or RAC certification preferred) + 10+ years of progressive experience in Quality Assurance within the medical device or digital health… more
- AbbVie (Irvine, CA)
- …for some or all of the following manufacturing processes: pharmaceutical products, medical devices , combination products and biologics. Specific areas of support ... *Ensures that product is consistently manufactured in conformance with AbbVie Quality System requirements and all applicable regulatory requirements. *Supplier… more
- Stryker (Irvine, CA)
- …engineering or related discipline. + 4+ years' related experience required. + Medical device industry experience required. + Familiarity with New Product ... quality documentation to support new product development and regulatory submissions. + Maintain and improve quality ...or Black belts are preferred. + Experience with the medical device development lifecycle, including risk management… more
- Cordis (Irvine, CA)
- …, joining the Quality team, will be responsible for ensuring that our medical devices meet the highest quality standards throughout the manufacturing ... risk mitigation to ensure the safety and efficacy of medical devices . + Regulatory Compliance:...regulatory requirements, standards, and guidelines relevant to the medical device industry and ensure that manufacturing… more
- Abbott (Alameda, CA)
- … devices , customer complaints, and product nonconformances. Prior experience in the medical device industry and/ or quality systems are required. + ... of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines....FDA Code of Federal Regulations as it applies to medical device manufacturing, including cGMP, ISO14971, as… more
- Abbott (Sylmar, CA)
- …US and non-US Quality System Requirements and other relevant regulations for medical devices . Previous experience with regulatory body. Knowledge of ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… more
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