- Philips (Cambridge, MA)
- …business unit. + Review inbound and outbound shipping to ensure import/export compliance , to include export licenses, duty drawback, FDA clearance, harmonized ... quality management system on export control and ensure compliance based on Export Control Laws and Regulations (written...Obtain and maintain partnering governing agency information such as FDA , EPA, etc. + Keeping Philips current with the… more
- Hologic (Marlborough, MA)
- …by the FDA , notified bodies, and other regulatory agencies. + Quality System Compliance : Ensure adherence to applicable regulatory standards, including ISO ... The Manager of Quality Engineering will lead quality strategies to ensure compliance with regulatory...13485, FDA QMSR and other applicable requirements. + Review and… more
- Takeda Pharmaceuticals (Boston, MA)
- …to monitor the health of the QMS including the identification of systematic quality compliance risks and implementation of robust mitigation plans + Engage ... Lead CPMQ continuous improvement initiatives to enable optimization of clinical and safety quality compliance activities. + Provide expert advice and support to… more
- Actalent (Lexington, MA)
- …+ Direct and oversee the Quality Assurance team and daily operations + Ensure compliance with FDA regulations, GMP, GxP, and internal quality standards + ... Quality Assurance (QA) team, overseeing all aspects of quality systems and regulatory compliance . This role...Core Skills: + Quality Assurance and regulatory compliance + Audit management and FDA interaction… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Global Quality Lead, GMP, GDP Audit and Inspection - Pipeline Launch **Location:** Framingham, MA or Morristown, NJ **About the Job** We deliver 4.3 ... technology and diverse talents to secure product launches and support compliance through audits, inspections, regulatory surveillance, and advocacy. Grounded in core… more
- Fresenius Medical Center (Waltham, MA)
- …These core values are, Patients and Partners First, Honesty and Integrity, Quality and Compliance , Collaboration, No-Limits Mindset and Results Oriented. ... to existing quality or production systems to optimize product quality while ensuring compliance with regulatory requirements and internal Fresenius… 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...review and release, and investigation activities to ensure strict compliance with GMP standards and regulatory expectations. Key Responsibilities:… more
- Integra LifeSciences (Braintree, MA)
- …continuous improvement **SUPERVISION RECEIVED** Under direct supervision of Sr. Quality Compliance Manager, Environmental Controls. **SUPERVISION EXERCISED** ... 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
- Hologic (Marlborough, MA)
- …DE, United States Marlborough, MA, United States Are you passionate about ensuring compliance , driving supplier quality improvements, and making an impact in the ... medical device industry? Hologic is seeking a **Principal** **Supplier Quality Auditor** to play a critical role in maintaining...a critical role in maintaining the integrity and regulatory compliance of our supply chain. In this role, you'll… more
- Boston University (Boston, MA)
- **HUMAN RESEARCH QUALITY MANAGER, School of Medicine, Clinical Research** **Job Description** **HUMAN RESEARCH QUALITY MANAGER, School of Medicine, Clinical ... Type** Full-Time/Regular The Human Research Protection Program (HRPP) Human Research Quality Manager will perform quality assurance monitoring and auditing… more
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