- Fresenius Medical Center (Waltham, MA)
- …to existing quality or production systems to optimize product quality while ensuring compliance with regulatory requirements and internal Fresenius ... and experience required + Minimum 10+ years' experience in quality management, regulatory compliance, quality ...related industries + Several years of practical experience in FDA inspections and cooperation with US regulatory … more
- Insight Global (Bedford, MA)
- …ISO 13485, ISO 14971, IEC 62304, IEC 62366, AAMI TIR57). - Deep understanding of quality / regulatory standards for SaMD and SiMD. - Proven ability to apply ... a risk-based approach. - Experience with AI/ML models. - Familiarity with international regulatory landscapes beyond FDA and EU MDR. - Demonstrated judgment in… more
- AbbVie (Waltham, MA)
- … to prepare submissions and partic + Makes key decisions on product quality , compliance and regulatory conformance issues for sterile, biological, liquid, ... legal supply agreements, contractors or letters of intent to ensure that the appropriate quality , compliance and regulatory aspects are met for the products and… more
- Catalent Pharma Solutions (Chelsea, MA)
- …establish and maintain comprehensive systems that establish, document and monitor Quality standards and requirements that meet Catalent, Regulatory and ... Quality and Compliance standards and requirements, with preferable FDA experience; + Demonstrated knowledge of Change management and... Regulatory Inspections from both EU and US Regulatory agencies such as MHRA, IBM, FDA ,… more
- Charles River Laboratories (Wilmington, MA)
- …identified compliance and quality risks to his/her supervisor. + Provide quality assurance monitoring of projects to assure regulatory compliance of complex ... We have an exciting opportunity for a Specialist, Global Computer Validation Quality Assurance for Corporate located remotely. Provide quality assurance… more
- System One (Devens, MA)
- …approve executed batch records; support lot disposition + Participate in internal audits, FDA inspections, and client audits + Support quality systems, document ... Title: Senior Quality Assurance Associate Location: Devens, MA Type: 6-month...activities to ensure strict compliance with GMP standards and regulatory expectations. Key Responsibilities: + Perform GMP walkthroughs and… more
- Integra LifeSciences (Braintree, MA)
- …and manage time to meet organizational goals and objectives. + Experience with External Regulatory Agency audits (ie, Notified Bodies and FDA ). + Knowledge of ... challenging what's possible and making headway to help improve outcomes. The Senior Quality Engineer I - Design & Reliability Assurance (DRA) is responsible for the… more
- Integra LifeSciences (Braintree, MA)
- …and manage time to meet organizational goals and objectives. + Experience with External Regulatory Agency audits (ie, Notified Bodies and FDA ). + This position ... 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… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …Summary** We are seeking an experienced and dynamic Executive Director of R&D Global Quality to join our team. This pivotal role will be responsible for leading a ... global team focused on R&D Quality . This global role includes direct reports in the...submission support, lead the R&D audit program, engage with regulatory authorities, and maintain clinical data integrity. The leader… more
- Takeda Pharmaceuticals (Boston, MA)
- …auditing and monitoring processes, and ensuring compliance with corporate and regulatory standards. By maintaining high- quality standards, this role supports ... **Job Description** **About the role:** The Associate Director, Clinical and Safety Quality Compliance is responsible for ensuring the quality of processes… more