Senior Staff Design Quality Engineer
On-siteTrumbull, Connecticut, United States
Job Summary
Ensure safety, effectiveness, and compliance of medical devices throughout the design and development lifecycle by implementing and maintaining robust quality management systems. Lead design control and risk management activities across multiple projects, executing plans for strategic goals while collaborating with cross-functional teams including R&D, Operations, Regulatory, Supplier Quality, and Clinical. Provide technical leadership to apply design controls, risk management, and verification principles for safe product development in accordance with industry standards and customer requirements. Offer expert guidance on scientific and technical data for product testing, lead teams to solve complex product problems, and mentor peers and less experienced engineers through coaching and training.
Required Qualifications
- Senior technical individual contributor
- Subject-matter expert and technical authority in one or more specified DQE domains
- Knowledge of design controls
- Knowledge of risk management
- Knowledge of verification and validation principles
- Knowledge of quality engineering techniques
- Knowledge of applicable industry standards
- Knowledge of regulatory requirements
- Knowledge of customer requirements
- Expertise in scientific and technical data as it pertains to product and product testing
- Ability to lead teams to identify and solve complex product problems
- Ability to provide mentorship including coaching, reviewing, training, and delegating work to peers, leads, and cross-functional engineering teams
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