- Philips (Cambridge, MA)
- **Sr. Quality Engineer - CAPA Expert** **In this role you** CAPA subject matter expert who can confidently advise and critically review Corrective and ... Preventive Actions (CAPAs) in various stages of the CAPA workflow and facilitate CAPA investigations from...quality problem solving. Project manage all aspects of CAPA activity which includes gaining the commitment of cross… more
- Integra LifeSciences (Mansfield, MA)
- …new treatment pathways to advance patient outcomes and set new standards of care. The Senior Quality Systems Engineer is responsible for supporting the site ... improvements to the QMS, having oversight of and ensuring compliance to the Complaint, CAPA , Audit, and Quality Planning processes, acting as the Internal Audit… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Senior Quality Engineer **Location:** Framingham, MA **About the Job** We are an innovative global healthcare company with one purpose: to ... core leadership principals. + Develop integrated work plans and represent the Quality Assurance CAPA -Deviation- Investigation (CDI) team on integrated work… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Senior Quality Engineer , Contamination Control **Location** : Framingham, MA **About the Job** We deliver 4.3 billion healthcare solutions to ... of cGXP regulations and guidance. + Demonstrated experience with change control, CAPA and deviation quality systems. + Demonstrated proficiency in critical… more
- Integra LifeSciences (Boston, MA)
- …patient outcomes and set new standards of care. This position is for a Sr. Supplier Quality Engineer l - Global Supplier Quality with hands-on experience and ... proven success in managing Supplier Quality system while supporting and leading strategic initiatives to build a robust supplier quality system for the… 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 ... into the facility. Leading investigational activities around non-conformances and CAPA 's. Works collaboratively with Manufacturing, Engineering, Quality … more
- Sanofi Group (Framingham, MA)
- **Job Title:** Senior Quality Engineer , QMS **Location** : Framingham, MA **About the Job** We deliver 4.3 billion healthcare solutions to people every year, ... bring hope to patients and their families. Join our Quality Operations team at Framingham Biologics facilities! We support...drive continuous improvements. As a key user of the CAPA , Deviation, and Investigation (CDI) QMS, you'll oversee system… more
- Integra LifeSciences (Boston, MA)
- …pathways to advance patient outcomes and set new standards of care. The Senior Manufacturing Engineer will lead and support engineering projects and operations ... and regulatory compliance, in a medical devices regulated industry. The Senior Manufacturing Engineer will be responsible for identifying opportunities… more
- Tecomet (Woburn, MA)
- …The Supplier Quality Engineer is responsible for managing supplier quality , and leading the CAPA program for supplier non-conformances. Coordinates and ... drives improvements in quality , cost, and delivery. Extensive knowledge of quality system requirements ISO 13485 & CFR 820. Relies on experience and judgment to… more
- Integra LifeSciences (Mansfield, MA)
- …experience documenting, reviewing and approving CAPAs required. Previous experience managing CAPA process desired. Previous experience providing Quality Systems ... set new standards of care. Supports maintenance of the Quality management System, ensuring compliance to regulations and internal...+ Assists in the initiation, processing, and completion of CAPA records in the electronic system. + Leads meetings… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Senior Compliance Engineer **Location** : Framingham, MA or Northborough, MA **About the Job** We deliver 4.3 billion healthcare solutions to ... of cGXP regulations and guidance. * Demonstrated experience with Change Control, CAPA and deviation quality systems. **Preferred Qualifications:** * Technical… more
- Integra LifeSciences (Mansfield, MA)
- …with validation and engineering documentation. + Change control, non-conformance and CAPA support. + Participate in FDA inspections, ISO certifications, surveillance ... ability required for this position. + Bachelor's degree in engineering ( Quality , Mechanical, Chemical, or Electrical) or Science (Biology, Chemistry) in preferred.… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Principal Quality Engineer - Quality Assurance Contamination Control **Location** : Framingham, MA **About the Job** We deliver 4.3 billion ... lead, Quality Assurance, the Environmental Action Committee (EAC) and senior leadership. + Actively support work plans with other contamination control teams… more
- Actalent (Westborough, MA)
- …Experience using industry Problem Solving Tools such as 8D, Fishbone/Cause-Effect, or CAPA methodology. + Experience using Quality -Statistical tools such as ... Job Title: Process EngineerJob Description The Process Engineer will be responsible for the design, development, installation, and validation of manufacturing… more
- Amazon (Westborough, MA)
- …for a Co-op assignment. The candidate will have the opportunity work with senior engineering staff on existing and new and existing tools, mechanisms, modules and ... can potentially handle multiple parallel tasks. This position reports to a Hardware Development Engineer on the Amazon Robotics team. This role is a 6 month co-op to… more
- Medtronic (Boston, MA)
- …innovation in a more connected, compassionate world. **A Day in the Life** Quality leadership opportunities At Medtronic, we're driven by a commitment to Quality ... focus on excellence means we're always looking for talented Quality leaders to join our team. If you have...with customers + Experience with or conversant with the CAPA process + Experience in interacting with manufacturing sites… more
- Astellas Pharma (Westborough, MA)
- …subject matter expert, audit hosting / support, etc. + ASQ certifications (eg, certified quality engineer , quality auditor, quality professional, etc.) ... Medicine (AIRM)** site in **Westborough, MA.** **Purpose:** This member of the Quality Assurance team will perform critical QA compliance tasks in support of… more
- Astellas Pharma (Westborough, MA)
- …subject matter expert, audit hosting / support, etc. + ASQ certifications (eg, certified quality engineer , quality auditor, quality professional, etc.). ... The successful candidate will foster compliance across a broad range of Quality Assurance areas and will work closely with talented counterparts in the… more