- Fresenius Medical Center (Waltham, MA)
- **PURPOSE AND SCOPE:** The Senior Engineer , CAPA is responsible for coaching CAPA Engineers to ensure CAPAs (corrective and preventive action) and ... DUTIES AND RESPONSIBILITIES:** + Utilizes Quality System to ensure CAPA system is successful and compliant. Partners with Quality...+ Responsible for assigned CAPAs and will act as CAPA lead to CAPA Owner/Team providing project… more
- Fresenius Medical Center (Waltham, MA)
- **PURPOSE AND SCOPE:** The CAPA Quality Engineers are assigned Corrective Action and Preventive Action ( CAPA ) investigations as well as Non-Conformance (NC) ... NCs. **PRINCIPAL DUTIES AND RESPONSIBILITIES:** + Utilizes Quality System to ensure CAPA system is successful and compliant. Partners with Quality Systems personnel… more
- Medtronic (Billerica, MA)
- …opening will close on - 11 Jun 2025 Position Description: Principal Quality Engineer for Medtronic, Inc located in Billerica, MA. Develop, modify, apply and maintain ... Validations (TMV) or Gage R&R. Coordinates Corrective & Preventive Actions ( CAPA ) using TrackWise or similar QMS software tools, Nonconformance, Change Control,… more
- Medtronic (Boston, MA)
- …this opening will close on - 6 Aug 2025 **Position Description:** Sr. Software Engineer for Covidien LP (a Medtronic company) located in Boston, MA. Responsible for ... Python, QT and QML, leveraging operating systems and compilation. Investigate CAPA (Corrective and Preventative Action), identify software defects, propose software… more
- Materion (Newton, MA)
- …Semi-Conductor industry. Under the direction of the Quality Manager, the Quality Engineer - Semiconductor Manufacturer will be actively involved with the eQMS, with ... Work with them and audit them. + Investigate nonconformance reports and coordinate CAPA and continuous improvement actions. + Conduct internal audits for systems and… more
- Danaher Corporation (Shrewsbury, MA)
- …which makes everything possible. The Quality Assurance Engineer (Design & Manufacturing) is responsible for providing ... standards and driving process improvements; leading root cause analysis and CAPA initiatives, ensuring timely resolution of nonconformances to maintain product… more
- Tecomet (Wilmington, MA)
- **Job Summary:** The Senior Quality Engineer will interact with team members to ensure compliance and internal and external customer requirements are met. Will work ... RMA processes. + Investigate customer complaints including associated actions including CAPA , deviations, and complaint responses. + Special projects as assigned by… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Automation Engineer III **Location** : Framingham, MA **About the Job** We deliver 4.3 billion healthcare solutions to people every year, thanks to ... and deliver future enhancements for automation related systems. The Automation Engineer III will be responsible for using expertise to design innovative… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Automation Engineer Senior **Location** : Framingham, MA **About the Job** We deliver 4.3 billion healthcare solutions to people every year, thanks to ... and bring hope to patients and their families. The Senior Automation Engineer ensures reliable operation and implementation of all automation systems, specifically… more
- Teleflex (Chelmsford, MA)
- Quality Engineer II, Design Assurance (Contract Role- end of 2025) **Date:** May 12, 2025 **Location:** Chelmsford, MA, US **Company:** Teleflex **Expected Travel** ... As a member of a cross-functional team, the Quality Engineer II, Design Assurance is responsible for identifying and...appropriate corrective and preventive action. Use the NC and CAPA systems as needed to structure activities. * Provide… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Automation Engineer , Building Automation **Location** : Framingham, MA **About the Job** We deliver 4.3 billion healthcare solutions to people every ... and deliver future enhancements for automation related systems. The Building Automation Engineer will be responsible for technical system ownership as the system… more
- Actalent (Auburndale, MA)
- Job Title: Principal Quality Engineer Job Description We are seeking an ambitious Principal Quality Engineer in the greater Boston area. Responsibilities + ... Root Cause Analysis activities stemming from MRB, RMA, and CAPA . + Analyze/trend non-conformances through NCMRs and RMAs. +...years of experience as a Quality or Design Quality Engineer in the medical device industry. + Working knowledge… more
- Amazon (Westborough, MA)
- …to drive a high bar for quality and performance. As a Field Quality Engineer , you will use your technical knowledge and specialized skills to support, build, ... implementation - Understanding of quality tools and methodologies (Six Sigma, 8D, CAPA , FMEA) Preferred Qualifications - Knowledge of SolidWorks simulation or Ansys… more
- Tecomet (Wilmington, MA)
- ** Engineer , Manufacturing** **Position Summary** The Manufacturing Engineer will develop and implement optimal, cost-effective manufacturing processes and ... regulatory requirements and concepts including ISO 13485, ISO 14971, MDR 2017/745, CAPA , NCR, supplier control, manufacturing control, design control. + Knowledge of… more
- Actalent (Waltham, MA)
- …for processing. + Manage Root Cause Analysis activities stemming from MRB, RMA, and CAPA . + Analyze and trend non-conformances through NCMRs and RMAs. + Assist in ... Minimum of 10 years of experience as a Quality or Design Quality Engineer in the medical device industry supporting the development of complex electro-mechanical… more
- Takeda Pharmaceuticals (Lexington, MA)
- …best of my knowledge. **Job Description** About the role: As the Packaging Engineer you will oversee Takeda's global Small Molecule & Oncology external supply ... packaging / product integrity + Lead change control, non-conformances and CAPA activities working with the CMO (Contract Manufacturing Organization) and internal… more
- Amazon (Westborough, MA)
- …at the right time to enable our automated solutions. The Sr. Process Engineer will be responsible for participating in the development of strategic, large scale ... Experience using industry Problem Solving Tools such as 8D, Fishbone/Cause-Effect, or CAPA methodology. - Experience using Quality & Statistical tools such as PFMEA,… more
- Bristol Myers Squibb (Devens, MA)
- …lives. Read more: careers.bms.com/working-with-us . **Position: Manager, Validation Engineer , Cell Therapy** **Location: Devens, MA** **Key Responsibilities** + ... and resolve complex challenges. + Investigate and resolve Validation Deviations, CAPA investigations and other potential issues + Works with Automation/IT partners… more
- Bristol Myers Squibb (Devens, MA)
- …immune system to treat cancer. **Position Summary** We are looking for a Senior Engineer 1 to join the raw materials team within the Cell Therapy GMSAT (Global ... and organizations. + Experience with Quality Management System (Ex. Deviation, CAPA , Change Management). + Knowledge of GMP manufacturing practices and documentation… more
- Tecomet (Wilmington, MA)
- **POSITION SUMMARY:** The Quality Engineer I will interact with team members to ensure compliance and internal and external customer requirements in the Aerospace ... by facts; + Investigate customer complaints including associated actions including CAPA , deviations, and complaint responses; + Special projects as assigned by… more