16159 Quality Systems Engineer I

Job Description: Develop and maintain procedures required to support the Quality System. Will help refine each of these programs or develop best practice examples of key quality system deliverables in compliance with FDA regulations and interpretations. Be a resource to operations teams to ensure appropriate application of quality system elements, especially as new or modified elements are introduced. Coordination, interpretation, and communication of Quality Systems metrics is a must as it relates to Management Review (e.g., complaints metrics, nonconforming product metrics, internal audit results, results from external audits by regulated bodies, compliance changes, etc.).

Knowledge of international standards and regulations (e.g, FDA, ISO 13485, MDD) is preferred. Demonstrated ability to develop SOPs and guidance documents using good technical writing practices. Ability to communicate key ideas verbally and in writing clearly and concisely to include presentations to management and to cross-functional team members. Combination of assertiveness and tactfulness essential. Bachelor's degree required, preferably engineering or related science.

Searchable Keywords: 16159 Quality Systems Engineer I / gj-mo

Minimum Education Required: Bachelor

Years of Experience Required: Entry Level

Expected Travel Time: About 25%


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.