- 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
- 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
- Olympus Corporation of the Americas (Westborough, MA)
- …in a robust and timely manner. + Act as Audit Finding coordinator. + Support CAPA process, monitor progress of records, help facilitate CAPA board meetings, and ... support CAPA owners to drive closure of corrective action plans. + Show strong ability to influence without direct authority across functional groups, regions, and leadership. + Provide resident expertise in the application of Quality Sciences including… more
- Hologic (Marlborough, MA)
- Lead Systems Engineer Newark, DE, United States Marlborough, MA, United States We are seeking two **Lead Systems Engineers** responsible for leading design, ... Risk management standards (eg, ISO 14971) and post-market surveillance processes (eg, CAPA ). Skills We're looking for someone who excels in: + Strategic Leadership:… 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 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
- 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
- Hologic (Marlborough, MA)
- Senior Systems Engineer Newark, DE, United States Marlborough, MA, United States Are you passionate about developing cutting-edge medical devices and solving complex ... technical challenges? At **Hologic** we're looking for a **Senior Systems Engineer ** to drive product sustainment, improve design history compliance, and collaborate… more
- Sanofi Group (Northborough, MA)
- **Job Title:** Operations Compliance Engineer Senior **Location:** Northborough, MA **About the Job** We deliver 4.3 billion healthcare solutions to people every ... and bring hope to patients and their families. **The Operations Compliance Engineer Senior** is responsible for the daily activities at the Northborough facility,… 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
- 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
- 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
- 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
- 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
- Bristol Myers Squibb (Devens, MA)
- …BMS quality management system including but not limited to deviation and CAPA action management, interim production controls, disposition decisions, and batch record ... records such as change control, product complaints, deviations, investigations, and CAPA management. + Experience working in aseptic/sterile environments and/or in… more