- Stryker (San Jose, CA)
- … Device (SaMD)/Software in a Medical Device (SiMD) and non-medical device software to support projects as a quality engineer for post-market activities ... **Stryker** is hiring a **Staff** **Software Quality Engineer, Post Market** to support our Medical's...device software post-market activities to ensure compliance and quality , proficient in Salesforce, SAP, TrackWise, Jira, and related… more
- Abbott (Alameda, CA)
- …Our 114,000 colleagues serve people in more than 160 countries. **Job Title** ** Quality Engineer II** **Working at Abbott** At Abbott, you can do work that ... preventative action of medical devices, including software as a medical device (SaMD), in-vitro, diagnostic devices, consumer devices, and accessories. **What You'll… more
- US Tech Solutions (San Bruno, CA)
- …of medical device software standards such as IEC 62304. **Software Quality Engineering Expertise:** 1. Hands-on experience in Software Quality Engineering ... for a person based on a comprehensive view of the evidence. **Responsibilities:** ** Quality Assurance Champion:** 1. Act as a champion of Quality Assurance… more
- Edwards Lifesciences (Irvine, CA)
- Imagine how your ideas and expertise can change a patient's life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of ... pioneering technology. In this role, you will apply your knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements… more
- Abbott (Menlo Park, CA)
- …in the Structural Heart division. Our business purpose is to restore health and improve quality of life through the design and provision of device and management ... for the treatment of structural heart disease. As the Senior Development Quality Engineer, you'll be responsible for ensuring that risk management is effectively… more
- Adecco US, Inc. (Cupertino, CA)
- …week). **Job Summary:** We are seeking an experienced and detail-oriented **Labelling/ Quality Compliance Specialist** to support global medical device labelling ... in consumer technology and innovation in recruiting for a Labelling Specialist / Quality Compliance Specialist III in Cupertino, CA. This is a contract assignment… more
- Bausch + Lomb (Sacramento, CA)
- …(eg, R&D/Project Management, Clinical/Medical Affairs, Biometrics, Regulatory Affairs, Quality Assurance, Pharmacovigilance/GPSS and Drug/ Device Safety, and ... provide input on study-related documents and issues (DMP, SAP, drug/ device supplies, CSR, etc.). + Provides clinical operations input...ICH, GCP and B&L SOPs. + Responsible for the quality of all study-related documentation (eg, Trial Master File,… more
- BD (Becton, Dickinson and Company) (Irvine, CA)
- …and other departments/business units for complaint investigations + Evaluate complaints for Medical Device Reporting (MDR) + Prepare and submit MDR reports to FDA + ... meetings to discuss complaint issues with affected functions (eg, Manufacturing, Quality Assurance, Suppliers, etc.) to identify assignable root cause, resolve open… more
- Cordis (Irvine, CA)
- …the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery ... solutions that address unmet and critical medical needs. The **Principal Manufacturing Quality Engineer** will be responsible for ensuring that our medical devices… more
- J&J Family of Companies (Irvine, CA)
- …Enterprise, Medical Device and CSS policies and goals. + Product Quality - Oversees directly and indirectly organization of Quality professionals, such ... preventive action, records management and document control, complaint management and medical device reporting and management of quality data across disciplines.… more