Shsjb
Senior Quality Engineer, Quality Engineering
Shsjb, Walpole, Massachusetts, United States, 02081
Quality Engineering Position
Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. An experienced Quality Engineering position at Walpole, which is involved in developing, implementing, maintaining, and improving systems to ensure products are designed and produced to meet or exceed customer requirements and expectations. The candidate ensures consistent implementation and compliance to the Siemens Healthcare Diagnostics Quality System and external regulations. In the Walpole location, the QE's responsibilities include providing Quality Engineering support for Design Transfer, Design Changes, Change Control, Process Validation, and Risk Management processes. Key functions of the QE role include: Serving as the quality representative on the element team during the technical transfer from design to manufacturing. Supporting ongoing product and process changes post-manufacturing. Providing leadership in design control, process validation, and risk management within a Class II and Class III IVD reagent manufacturing facility. The Quality Engineer (QE) provides independent oversight and review of project deliverables throughout the lifecycle. They actively participate in the change management process to ensure products continue to meet customer requirements and collaborate as part of a cross-functional team alongside business and engineering disciplines. The QE reports to the Senior Quality Engineering Manager. Required Knowledge/Skills, Education, and Experience: BS in Life Science or Engineering discipline with a minimum of 5 years of experience in the medical device, pharmaceutical or biotechnology industry. Strong knowledge of FDA Quality System Regulation (QSR) with an emphasis on Process Validation and Design Controls; ISO 13485; and ISO14971. Proven experience providing quality engineering leadership to project teams in the areas of Design Controls, Process Validation and Control, and Risk Management.
Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. An experienced Quality Engineering position at Walpole, which is involved in developing, implementing, maintaining, and improving systems to ensure products are designed and produced to meet or exceed customer requirements and expectations. The candidate ensures consistent implementation and compliance to the Siemens Healthcare Diagnostics Quality System and external regulations. In the Walpole location, the QE's responsibilities include providing Quality Engineering support for Design Transfer, Design Changes, Change Control, Process Validation, and Risk Management processes. Key functions of the QE role include: Serving as the quality representative on the element team during the technical transfer from design to manufacturing. Supporting ongoing product and process changes post-manufacturing. Providing leadership in design control, process validation, and risk management within a Class II and Class III IVD reagent manufacturing facility. The Quality Engineer (QE) provides independent oversight and review of project deliverables throughout the lifecycle. They actively participate in the change management process to ensure products continue to meet customer requirements and collaborate as part of a cross-functional team alongside business and engineering disciplines. The QE reports to the Senior Quality Engineering Manager. Required Knowledge/Skills, Education, and Experience: BS in Life Science or Engineering discipline with a minimum of 5 years of experience in the medical device, pharmaceutical or biotechnology industry. Strong knowledge of FDA Quality System Regulation (QSR) with an emphasis on Process Validation and Design Controls; ISO 13485; and ISO14971. Proven experience providing quality engineering leadership to project teams in the areas of Design Controls, Process Validation and Control, and Risk Management.