- J&J Family of Companies (Santa Clara, CA)
- …Familiarity with FDA guidance documents and ISO and + ASTM standards related to quality and medical device industry. + Independently assesses if components, ... Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated… more
- US Tech Solutions (San Bruno, CA)
- … System Regulations, ISO 13485, and integration of best practices from the medical device industry. **Documentation and Support:** 1. Support the creation and ... and support CAPA, complaints, audits, and overall QMS functions. **Experience:** ** Medical Device Software Experience:** 1. Proven experience in software… 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
- J&J Family of Companies (Santa Clara, CA)
- …Director or above in a quality function across Design and Development including End-to-End Quality & Compliance in Medical Device . + Must have a minimum ... of 5 years of large-scale Capital Medical Device Equipment experience as a quality leader...investigations involving medical devices. + Work with quality and regulatory teams to ensure maintenance… more
- Abbott (Alameda, CA)
- …+ Must have 5+ experience in Software Quality Assurance. + Knowledge of medical device standards including FDA QSR, ISO 13485, ISO 14971, 21 CFR Part ... File (DHF) and Device Master Record (DMR) are in compliance with regulatory standards and quality management policies and procedures. + Develops and… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …technical field + Minimum of 10 years of experience in Quality or Regulatory function within the medical device industry, including experience with Class ... Collaborates with leadership in Business Unit Quality , Regulatory Affairs, R&D, Operations, Service, Medical Affairs,... Quality Operations, etc.) + Experience in full Medical Device product lifecycle. Ie Demonstrated … more
- Stryker (San Jose, CA)
- …skills + Experience with regulatory agencies (FDA, MoH, TUV) and medical device regulations (820, IEC 62304/82304, 60601), with experience in Software ... 's Digital Health division and portfolio Software as a Medical Device (SiMD) or Software in a...+ Partner with cross-functional teams, including marketing, R&D, clinical, regulatory , and operations, to deliver quality , compliant… more
- Terumo Neuro (Aliso Viejo, CA)
- …regulations, standards, good clinical practices, and guidelines applicable to the medical device industry to contribute to overall quality and regulatory ... **12870BR** **Title:** Sr Specialist, Clinical Trial Quality Assurance **Job Description:** Provide support to all...standards, good clinical practices, and guidelines applicable to the medical device industry. + Identify gaps and… more
- Stryker (San Jose, CA)
- …Software as a Medical Device (SaMD)/Software in a Medical Device (SiMD) to support projects as a quality engineer for post-market activities to drive ... working in the areas of Research & Development (R&D), Quality (QA/QC), Information Technology, Healthcare IT, Regulatory ...strong technical skills. + Experience with Software as a Medical Device (SaMD) and Software in a… more
- AbbVie (Irvine, CA)
- …*Ensures that product is consistently manufactured in conformance with AbbVie Quality System requirements and all applicable regulatory requirements. *Supplier ... product launches and tech transfer. *Ensure proper integration and support of quality regulations: drug, biologics, device and/or combination products. *Assist… more