Senior Development Quality Engineer

Job Overview

• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• Initiates and completes technical activities leading to new or improved products or processes for current programs, next-generation programs, and to meet strategic goals and objectives of the company.
• Prepares reports, publishes, and makes presentations to communicate findings.
• Analyzes and solves problems ranging from basic engineering principles, theories, and concepts to complex and advanced problems which require Client and new innovative approaches or a major breakthrough in technology.
• Understands and can apply engineering principles theories, concepts, practices, and techniques.
• Develops knowledge in a field to become a recognized leader or authority in an area of specialization and applies this knowledge in leadership roles in the company.
• Incorporates business policies and procedures into task completion.
• Cultivates internal and external networks of resources to complete tasks.
• Builds strategic partnerships with internal and external stakeholders to further departmental and organizational objectives.
• Supports the project team, determining goals and objectives for the projects.
• Recommends and implements changes to the system as the result of changing regulations and/or business needs.
• Analyzes data, makes decisions or provides recommendations to senior staff regarding quality related crises (e.g. patient injury due to product malfunction).
• Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.
• Identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Education / Experience

• Bachelor’s degree plus 0-2 years of related work experience.
• Working technical knowledge and application of concepts, practices and procedures.
• General understanding of business unit/group function.
• Will perform this job in a quality system environment.
• Failure to adequately perform tasks can result in noncompliance with governmental regulations.
• Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors.
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Has a broad knowledge of technical alternatives and an understanding of their impact on the systems environment.

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