- Abbott (Burlington, MA)
- …CA or Burlington, MA location in the Abbott Heart Failure Division Global Design Quality Department . This is an ONSITE position. In Abbott's Heart Failure (HF) ... get on with their lives. We are seeking an experienced **_Staff Software Quality Engineer_** to ensure our medical devices are developed in accordance with Abbott's… more
- Integra LifeSciences (Braintree, MA)
- …challenging what's possible and making headway to help improve outcomes. The Senior Quality Engineer I - Design & Reliability Assurance (DRA) is responsible for the ... a seasoned professional engineer with complete and in-depth conceptual knowledge of quality engineering. They are knowledge of quality engineering best practices… more
- Insight Global (Bedford, MA)
- …The position provides leadership at the project level, guiding quality and compliance in areas like development, cybersecurity, verification/validation, and ... on software compliance, including cybersecurity and privacy. Ensure product quality and documentation meet standards before approval. Support product development… more
- Charles River Laboratories (Wilmington, MA)
- …We have an exciting opportunity for a Specialist, Global Computer Validation Quality Assurance for Corporate located remotely. Provide quality assurance ... IT regulated activities. Essential responsibilities: + Communicate all identified compliance and quality risks to his/her supervisor. + Provide quality assurance… more
- Integra LifeSciences (Braintree, MA)
- …headway to help improve outcomes. This position is for a Sr. Manufacturing Quality Engineer l with hands-on experience and proven success in managing Quality ... pertain to sterility assurance and microbiology and drive cross-functional collaboration with quality groups across the organization. This role requires a strong … more
- Sanofi Group (Framingham, MA)
- **Job Title:** Global Quality Auditor **Location:** Morristown, NJ, Framingham, MA, Swiftwater, PA **About the Job** We deliver 4.3 billion healthcare solutions to ... Inspections. + Covers an international scope including major regulators; US FDA (USA), EMA (Europe), ANSM (France), National Medical Products Administration (China),… more
- Integra LifeSciences (Braintree, MA)
- …are challenging what's possible and making headway to help improve outcomes. The Quality Design and Reliability Assurance (DRA) Engineer II is responsible for the ... time (where applicable). + Support implementation of SPC programs with Manufacturing and Quality Control as a part of Process Validation and Design Transfer. +… more
- Nanobiosym, Inc. (Cambridge, MA)
- …and the coordination of processes pertaining to regulatory compliance and quality systems to ensure regulatory requirements for compliance DUTIES + Collaborate ... including the creation and documentation of validation protocols that comply with FDA regulations. + Provide troubleshooting focus and direction for the team with… more
- Cambrex High Point (Waltham, MA)
- …Strong working knowledge of GMP requirements, ICH guidelines, and regulatory expectations ( FDA , EMA). + Experience in quality control testing, stability ... manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career...Together with our customers, we aim to improve the quality of life for patients around the world. Start… more
- Bristol Myers Squibb (Devens, MA)
- …here at BMS with our Cell Therapy team. This is a key role on the Shop Floor Quality Assurance team. As Shift Manager for the A2 Shift (6pm to 6am), you will lead a ... team of 4-8 Specialists. The Shop Floor Quality Assurance team is responsible for 24x7 ...environment with limited information and/or time-constraints. + Experience in FDA /EMA regulations in biopharmaceuticals or cell therapy manufacturing is… more