Quality Assurance Specialist
4 weeks ago
The Hardware Quality Engineer plays a critical role in ensuring the quality and compliance of design for new product development and sustaining projects. This position requires a strong understanding of design controls, risk management, and test method development and validation.
The ideal candidate will have a background in engineering or a related field, with experience in a regulated industry such as medical devices. Strong communication and problem-solving skills are essential for success in this role.
Key Responsibilities- Contribute to planning and execution of design controls, risk management, and test method development and validation.
- Partner with R&D to determine and define design inputs, design outputs, and design input/output relationships.
- Develop and maintain the product risk management file, including updating based on post-market information.
- Support regulatory approvals and responses to regulatory questions.
- Assure quality of the Sustaining Engineering process for design and process changes to commercialized product.
- BA/BS in Engineering or physical sciences; Electrical, or Biomedical Engineering degree preferred.
- Three years of related experience in a regulated industry (e.g., military, automotive, aerospace); medical device and design assurance preferred.
- Advanced degrees and certifications are a plus.
This role requires occasional travel, with up to 20% of time spent on the road. The working environment is primarily office-based, with some time spent in a plant or manufacturing setting.
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