Senior Quality Engineer
Senior Quality Engineer
Location: Greater Dayton, OH
Summary
A medical device organization is seeking a Senior Quality Engineer to serve as a key technical leader and partner to quality and engineering leadership. This individual will play a critical role in shaping product quality strategy, with a strong emphasis on design evaluation, risk assessment, and influencing engineering decisions.
This is a high-impact position for someone who can operate as a trusted advisor and mentor, bringing deep mechanical and design perspective into quality while helping elevate team capability and processes.
Scope of Responsibilities
- Act as a senior technical partner to leadership, supporting complex quality and design-related decisions
- Mentor and guide junior engineers, serving as a go-to resource for best practices and problem solving
- Lead and influence key quality activities across product development, including:
- DFMEA / PFMEA
- Risk analysis and mitigation strategies
- Design change evaluation and decision support
- Collaborate cross-functionally with engineering, manufacturing, and supply chain to drive product quality improvements
- Translate design risks and FMEA outputs into clear, actionable insights
- Support development and continuous improvement of quality systems and processes (QMS)
- Apply Six Sigma and continuous improvement methodologies to enhance consistency and performance
- Communicate complex technical concepts effectively to a broad range of stakeholders
Requirements / Qualifications
- Bachelor's degree in engineering (mechanical preferred) with 6+ years of relevant experience
- Background in mechanical design, design engineering, or design assurance, with exposure to quality engineering
- Strong expertise in design-focused quality principles, not just testing or validation
- Hands-on experience with:
- DFMEA / PFMEA
- Risk analysis, root cause investigation, and design controls
- Change management within product development environments
- Ability to evaluate designs and guide others, rather than focusing on test execution
- Proven experience mentoring or influencing engineers across teams
- Familiarity with medical device regulations and standards (e.g., FDA, ISO) preferred
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