Principal Design Quality Engineer
2 weeks ago
At Treace, we are seeking a highly skilled Principal Design Quality Engineer to join our team. As a key member of our Research and Development organization, you will be responsible for leading and supporting key strategic projects, new product development, and providing quality oversight to ensure products meet quality standards consistent with internal procedures and acceptance criteria.
Key Responsibilities:- Lead new product qualification activities for new products and support product transfer activities to current and new suppliers.
- Provide Quality oversight and approval of qualification/validation/design control activities.
- Liaison with supplier quality representatives concerning issues with quality assurance.
- Lead and support in the creation of inspection models, inspection prints, gauging, or other inspection documents and detailed testing requirements to insure receipt of quality product.
- Lead and support in the creation and maintaining product and process risk management files to meet FDA and ISO standards.
- Evaluate product changes and direct appropriate disposition of product through the company's change control system.
- Participate in quality system audits (FDA, ISO, Internal, etc.) R&D and training cadaver labs.
- Collaborate with Surgeon Advisory Board, Marketing, and Design Engineers on new product feasibility to understand product needs and formulate design inputs.
- Provide technical guidance to project teams related to product testing, verification, validation, risk analysis, and design requirements.
- Review and assess the quality and technical rigor for manufacturability (DFM) of new product designs.
- Organize and lead project design reviews.
- Support concurrent engineering efforts as a participating design team member for product development projects representing quality assurance and the customer (supplier and end user).
- Bachelor's degree in engineering, Science, Technology, or a related discipline.
- Minimum of seven years (7+) of progressive medical device engineering experience in Quality, Development, and Manufacturing. Orthopedic medical device experience preferred.
- Familiarity working within an FDA compliant Title 21 section 820 environment.
- Certified Quality Engineer preferred.
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