- Terumo Neuro (Aliso Viejo, CA)
- …standards, good clinical practices, and guidelines applicable to the medical device industry to contribute to overall quality and regulatory compliance ... **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
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …planning for marketing collateral to support clinical products + Ownership of on-time quality assessments, medical device reporting and health risk ... bodies + Provide subject matter expertise into design of clinical trials for medical device development and submission to the FDA and other regulatory bodies +… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Assurance, you are responsible for: **Job** **Responsibilities:** * Serve as a lead quality engineer for medical device combination product development ... and suppliers to resolve complex technical issues related to drug- device combination products, processes, and quality . *...in quality assurance for the development of medical devices and/or drug- device combination products. **Preferred… more
- Gilead Sciences, Inc. (Foster City, CA)
- …possible, together. **Job Description** **Key** **Responsibilities:** + Serve as a lead quality engineer for medical device combination product development ... and suppliers to resolve complex technical issues related to drug- device combination products,processes, and quality . + Act...in quality assurance for the development of medical devices and/or drug- device combination products. +… more
- Caldera Medical (Westlake Village, CA)
- …is Caldera Medical ? Caldera Medical is a growth stage medical device company dedicated to improving the quality of life for women. In 2018, Caldera ... California Sponsorship is not available for this role Caldera Medical 's Mission - To Improve the Quality ...a Sr. Regulatory specialist, you will develop and implement medical device regulatory strategies to obtain timely… more
- Abbott (Menlo Park, CA)
- …You'll Work On** + Provide leadership in direct support of medical device manufacturing. + Management and development of Quality Engineers and Technicians. + ... serve people in more than 160 countries. **Senior Development Quality Manager** **Working at Abbott** At Abbott, you can...or mechanical engineering preferred. + Class III or II medical device experience (catheter experience preferred). +… more
- Actalent (Vista, CA)
- …require. Essential Skills + ISO auditing + Quality Management System (QMS) + Quality assurance + Medical device auditing + CAPA (Corrective and ... The QA Specialist is primarily responsible for overseeing the quality and regulatory aspects of the company. This includes...etc. to FDA authorities. + File Vigilance Reports or Medical Device Reports to Competent Authority or… more
- Caldera Medical (Westlake Village, CA)
- …is Caldera Medical ? Caldera Medical is a growth stage medical device company dedicated to improving the quality of life for women. In 2018, Caldera ... Analyst 100% ONSITE - in Westlake Village, California Caldera Medical 's Mission - To Improve the Quality ...requirements. * Ensure timely and accurate complaint evaluations, including medical device reporting (MDR) or equivalent regulatory… more
- Caldera Medical (Westlake Village, CA)
- …is Caldera Medical ? Caldera Medical is a growth stage medical device company dedicated to improving the quality of life for women. In 2018, Caldera ... Product Manager 100% ONSITE - Westlake Village, California Caldera Medical 's Mission - To Improve the Quality ...a related field (Master's/MBA preferred). * 7+ years of medical device product management with at least… 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