14433 Quality Systems Engineer II

Job Description: Responsible for the implementation, coordination and continuous review of the CAPA system, including interface with the corporate team on potential system improvements and next generation software program. Act as a coach to CAPA teams and managers in successfully initiating and executing CAPA projects. Support monthly CAPA review by assembling metrics information and scheduling project presentations. May lead system or site-wide CAPAs, applying sound, systematic problem-solving methodologies. Work with site trainer and corporate staff to ensure delivery of effective training on the CAPA system. Assemble information for quarterly recognition of completed CAPAs. Provide input on the further development of the global CAPA software system. Should have knowledge of international standards and regulations (e.g, FDA, ISO and MDD). Support quality systems team in compiling metrics for management reviews and key management meetings. Bachelors degree, preferably engineering or related science. Experience leading improvement teams using basic problem-solving tools and skills. Experience managing CAPA or comparable system, preferably in a medical device or pharmaceutical industry, desirable. Good communication skills as demonstrated through one-on-one experiences, team membership, or internal consulting opportunities. Ability to communicate key ideas verbally and in writing clearly and concisely. Combination of assertiveness and tactfulness essential.

Searchable Keywords: 14433 Quality Systems Engineer II / gj-mo

Minimum Education Required: Bachelor

Expected Travel Time: About 25%

This company may offer relocation assistance.


Boston Scientific offers incredible opportunities to grow and advance, a dynamic work environment and an excellent benefits package. Boston Scientific is an equal opportunity employer, M/F/D/V.