- AbbVie (Pleasanton, CA)
- …reading & interpreting mechanical drawings & GD&T + performing daily assigned tasks in compliance with FDA 's Quality System Regulation (QSR), ISO 13485, ISO ... or other technical discipline. Must have 1 year of quality engineering work experience in FDA regulated...year of quality engineering work experience in FDA regulated medical device manufacturing environment(s). If experience required,… more
- Robert Half Finance & Accounting (Oakland, CA)
- …costs, identifying optimization opportunities, and driving savings while maintaining the product quality required for FDA regulatory compliance . This is ... inefficiencies, and assess opportunities to reduce costs without compromising quality or compliance . + Monitor the cost...product lines. Compliance and Reporting: + Ensure compliance with FDA regulations by working cross-functionally… more
- Kelly Services (Petaluma, CA)
- …drive results without heavy oversight. **What You'll Do** + Partner with engineering and quality teams to ensure FDA compliance on validations, CAPAs, and ... process changes. + Prepare and support FDA submissions, including Class I device registrations, Class II...+ Develop and maintain SOPs tied to engineering processes, quality systems, and labeling compliance . + Lead… more
- US Tech Solutions (San Bruno, CA)
- …to high standards and corporate requirements. **Regulatory Compliance :** 1. Ensure compliance with US FDA Quality System Regulations, ISO 13485, ... **Training and Compliance :** 1. Provide ongoing training and education on quality systems and SDLC frameworks, and support CAPA, complaints, audits, and overall… more
- J&J Family of Companies (Santa Clara, CA)
- …a member of Johnson & Johnson's Family of Companies, is recruiting for Head of Quality and Compliance (Q&C) Leader for our Monarch platform. This role will ... is an end-to-end role with responsibilities including Design & Development, Manufacturing/Operations, Quality & Compliance and Post Market Surveillance. As a… more
- Oura (San Francisco, CA)
- …privacy and regulatory compliance with commercial objectives. What you will do: FDA & Global Regulatory Compliance : + Serve as the primary legal advisor ... on FDA , EU MDR, and other global health ...product development, clinical validation, and market positioning. + Oversee compliance with Quality System Regulation (QSR) and… more
- Abbott (Pleasanton, CA)
- …trends from various sources and proactively address regulatory, compliance , and quality issues. + Actively participate in FDA inspections and lead ... people to restore their health and get on with their lives. As a Senior Quality Compliance Manager, the individual will play a crucial role within Abbott's Heart… more
- BD (Becton, Dickinson and Company) (Irvine, CA)
- …scenarios: + Other duties assigned by Leadership (Attend cross-functional meetings to represent Quality Compliance and present open items for which resolution is ... **Job Description Summary** Fulfill FDA , ISO and other relevant requirements for designated...understanding of Edwards policies, procedures, and guidelines relevant to quality compliance + Proficient knowledge of medical… more
- Abbott (Alameda, CA)
- …medicines. Our 114,000 colleagues serve people in more than 160 countries. **Sr. Quality Compliance Specialist** **Working at Abbott** At Abbott, you can do ... + Support the development and delivery of training on audit readiness and compliance topics. + Participate in quality system improvement initiatives and support… more
- United Therapeutics (Sacramento, CA)
- …you're passionate about pharmacovigilance! You are a team player who loves quality , compliance , finding solutions and ensuring training standards are implemented ... This role in Global Patient Safety (GPS) will focus on enhancing and maintaining quality , training, and compliance (QTC) of GPS operations and practices. They… more