- 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
- DEKA Research & Development (Manchester, NH)
- …the highest standards of quality and compliance. Key responsibilities as a Quality Systems Engineer : + Own and manage the full CAPA process-from intake and ... be at the forefront of driving quality excellence! As our Quality Systems Engineer , you'll be a key player in our collaborative environment, working hand-in-hand… more
- DEKA Research & Development (Manchester, NH)
- …be at the forefront of driving quality excellence! As our Junior Quality Engineer , you'll be a key player in our collaborative environment, working hand-in-hand with ... including Excel, Word, and Visio. As a Jr. Quality Engineer , you will contribute in the following areas: +...related standards + Experience with Corrective and Preventive Action ( CAPA ) + 1+ years' experience in quality systems management,… 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
- 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
- Ferrotec USA (Bedford, NH)
- …and follows through on internal and external 8D corrective actions preventative actions ( CAPA ). * Able to work with and handle sensitive information. * Significant ... work experience and 8+ years' experience as a Quality Engineer . * Must be familiar with statistical tools and...BE SUCCESSFUL * 8+ years' experience as a Quality Engineer or 5 years' experience as a Quality … more
- DEKA Research & Development (Manchester, NH)
- DEKA R&D has an immediate opening for a Quality Engineer to work in the Quality Department in a dynamic Medical Device Research and Development environment. The ... to the Quality Manager. We are seeking a Quality Engineer to provide Quality guidance in a dynamic, fast-paced...devices, to provide guidance in Root Cause Analysis and CAPA . + Use experience with engineering and technology to… 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
- 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
- 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
- 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
- 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