- 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
- 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 (Northborough, MA)
- **Job Title:** Quality Engineer **Location:** Northborough, MA **About the Job** We deliver 4.3 billion healthcare solutions to people every year, thanks to the ... + Work closely with manufacturing, quality and support groups to develop effective CAPA . + Generate and present assigned metrics at the required frequency which… 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
- 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
- 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
- Takeda Pharmaceuticals (Lexington, MA)
- …job opportunity: **JOB LOCATION:** Lexington, MA **POSITION** : Sr. Cleaning Validation Engineer II **POSITION DESCRIPTION** : Shire Human Genetic Therapies, Inc. is ... seeking a Sr. Cleaning Validation Engineer II with the following duties: manage validation programs and projects. Develop validation strategies to test equipment and… 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
- Amgen (Cambridge, MA)
- …us and transform the lives of patients while transforming your career. Senior Sterilization Engineer **What you will do** Let's do this. Let's change the world. In ... projects for combination products sterilization processes + Support on-going deviation/ CAPA and change control + Support/ lead Amgen primary container system… 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
- 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
- MKS Instruments Inc (Wilmington, MA)
- A Day in Your Life at MKS: As a Supplier Quality Engineer at MKS' Global Supply Chain organization, you will partner with Global Supply Chain - Category Management, ... Project management skills. + Demonstrated use of Quality tools (FMEA, SPC, GR&R, CAPA /RCA, process validation (IQ, OQ, PQ) and auditing. Preferred Skills: + Direct… more
- Tecomet (Wilmington, MA)
- **POSITION SUMMARY:** The Quality Engineer II will interact with team members to ensure compliance and internal and external Aerospace and defense customer ... aerospace and defense customer complaints including associated actions including CAPA , deviations, and complaint responses; + Special projects as assigned… more
- Astellas Pharma (Westborough, MA)
- …+ Fluency in Deviation investigation techniques, root cause analysis methods, CAPA effectiveness verification, and product impact assessments. Working fluency in the ... oversight and compliance considerations. + ASQ certifications (eg, certified quality engineer , quality auditor, quality professional, etc.) + Experience with an… more