- Verista (Boston, MA)
- …new skills and learn from our experiences to enhance our collective expertise Quality Lead Responsibilities: This position will be responsible for supporting the ... to FDA / MHRA regulations + Use of computerized quality management systems + Experience with validation of Enterprise / Lab Computerized Systems. + Quality… more
- Wolters Kluwer (Waltham, MA)
- …expected data outcomes. Understands the needs and expectations of the assessment and validation of client problem. Ensures quality responses (written, verbal) to ... variables. + Responsible for performing ongoing clinical data analysis and quality control activities related to proprietary drug content and clinical decision… more
- Integra LifeSciences (Boston, MA)
- …time (where applicable). + Lead implementation of SPC programs with Manufacturing and Quality Control as a part of Process Validation and Design Transfer. + ... patient outcomes and set new standards of care. The Senior Quality Engineer I - Design &...for the development and implementation of new and updated Quality System procedures for ISO/QSR, such as validation… more
- RTX Corporation (Tewksbury, MA)
- …a safer, more secure world. We have an immediate need for an onsite Senior Software Systems Quality Engineer ( Quality Assurance/Compliance) to support Land ... dashboards). + Ability to create and submit MS PowerPoint presentations for/to Senior Management. + Familiarity with Quality Standards (ISO9001, AS9100, AS9115).… more
- J&J Family of Companies (Danvers, MA)
- …medical devices. + Ensure compliance of manufacturing processes and areas to all applicable quality system regulations. + Lead Quality reporting such as, key ... of Johnson & Johnson MedTech, is recruiting for a Senior Manufacturing Quality Engineer located in Danvers,...performance metrics, goals, and objectives. + Lead and support activities related to the Material Review… more
- RTX Corporation (Andover, MA)
- …meaningful problems that create a safer, more secure world. We are seeking a Senior Operations Quality Engineer with hands-on hardware quality experience to ... team discussions to drive process enhancements to reduce variation. + Lead /Drive Advanced Product Quality Planning (APQP) initiatives (PFMEA, control… more
- RTX Corporation (Andover, MA)
- …meaningful problems that create a safer, more secure world. We are seeking a Senior Operations Quality Engineer with hands-on hardware quality experience to ... manufacturing team discussions to drive process enhancements to reduce variation. Lead /Drive Advanced Product Quality Planning (APQP) initiatives (PFMEA, control… more
- Integra LifeSciences (Boston, MA)
- …new treatment pathways to advance patient outcomes and set new standards of care. The Senior Quality Engineer II is responsible for providing quality and ... for the development and implementation of new and updated Quality System procedures for ISO/QSR, such as validation...activities are being met + As required, assist or lead in the prompt implementation of Non-Conformance resolution. +… more
- Procter & Gamble (Andover, MA)
- …The PC&IS Senior Engineer owns PC&IS technologies from concept to validation , training, and startup and is often involved in defining the strategy, resources, ... Job Location Andover Job Description Role Description: The PC&IS Senior Engineer leads the electrical and controls definition, design, and delivery of… more
- Ryder System (Boston, MA)
- …and non-functional requirements, such as performance, security, and scalability. Reports to Quality Manager. Interacts with Quality Lead , IT Project ... and maintain test cases and documentation + Participation in Quality reviews and validation of requirements, architecture...+ Development and Training of Ryder's TCOE + Assist Quality Manager and Quality Lead … more
- Takeda Pharmaceuticals (Boston, MA)
- …pharmaceuticals, along with methods for achieving and controlling high standards of purity and quality . The Senior Staff Engineer - Process Modeling will join a ... within the function and potentially cross-functionally. + Identify topics for initiatives and lead local/global initiatives on behalf of senior staff. + Author… more
- Amgen (Cambridge, MA)
- …the lives of patients while transforming your career. Process Development Drug Product Senior Engineer **What you will do** Let's do this. Let's change the world. ... relationships with Contract Manufacturing partners, Global Operations, Contract Manufacturing Quality , and Drug Product process teams. + Demonstrate the ability… more
- Charles River Laboratories (Wilmington, MA)
- …the programming, design development, submittal reviews, construction, and commissioning/ validation phases. + Leverage engineering expertise (ie, HVAC, ... and remotely. + Ability to develop muti site programs and communicate to senior leadership, gain approval and manage / facilitate implementation. + Provide support… more
- Amgen (Cambridge, MA)
- …and transform the lives of patients while transforming your career. Process Development Senior Scientist - Analytical Chemist **What you will do** Let's do this. ... the technical aspects of developing analytical tools to gain understanding of key quality attributes in product and process for late phase synthetic small molecule,… more
- Astellas Pharma (Cambridge, MA)
- **Group Leader, Translational Medicine - Immuno Oncology ( Senior Director)** Do you want to be part of an inclusive team that works to develop innovative therapies ... Scope:** The primary purpose of the Translational Medicine Group Leader is to lead the development and implementation of the Translational Medicine strategy within a… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- The Senior Director, Precision Medicine Strategy Lead role is critical for the successful execution of Regeneron biomarker strategies. Will be accountable for ... strategic role responsible for independently designing, developing, communicating at senior levels and overseeing the implementation of clinical biomarker strategies… more
- Bank of America (Boston, MA)
- Senior Audit Manager - BSA/AML including Sanctions Charlotte, North Carolina;East Hartford, Connecticut; Plano, Texas; Boston, Massachusetts; Wilmington, Delaware; ... Executes assigned components of the audit plan in a timely manner, within quality standards and in conformance to audit policies and procedures. + Strategic… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Contacts + Internal: Research & Development, Facilities, IT, Engineering, Validation , Quality , Finance, Procurement, Inventory Management, Asset Management ... and empower you to shine? Join us as a Senior Manager, R&D Lab Operations in our Lexington, MA...other groups to assure seamless process integration, adherence to quality processes, compliance standards and support. + Manage and… more
- ICON Clinical Research (Boston, MA)
- …patients' lives. ** Senior Director, Design Control- Cambridge MA- Hybrid** + Lead and manage the IVD design control team, providing direction, support, and ... Senior Director, Design Control- Cambridge MA- Hybrid ICON...with applicable regulations and standards including assay development and validation and kit production. + Core understanding of the… more
- Bio-Techne (Waltham, MA)
- …both internal and external collaborations. Technology transfer, operationalization, verification, and validation , of nucleic and protein assays are all in scope. ... intended for diagnostic use at Exosome Diagnostics (ExoDx), + Verification/ Validation of assays that are FDA-approved, EUA-approved, FDA-modified, or laboratory… more