About The Role- Trains to all Quality System documents assigned in the applicable training plan.
- Authors, Updates, and Maintains all Quality Management System documents concerning Design Controls.
- Represents the Quality function as needed in meetings concerning design controls.
- Maintains a working knowledge of all applicable international standards concerning design controls.
- Develops plans for verification, validation, and useability activities in accordance with standards and directives.
- Reviews all product-level, system and sub-system-level, and component-level requirements for completeness and testability.
- Creates test cases to validate product-level requirements and to verify system-level requirements. Also capable of creating test cases for lower level requirements when necessary.
- Creates protocols for assessing useability of applicable requirements.
- Maintains traceability of subject requirements to the test cases that verify or validate them.
- Executes test cases on appropriate systems and accurately records the results.
- Enters defects into a defect tracking system when a system deficiency is encountered, providing sufficient detail for a development engineer to recreate and address the defect.
- Prepares appropriate reports to summarize the results of all testing activities.
- Other duties assigned by leadership
About The Role- Bachelor's degree (BS) in technical or life science field.
- Minimum of 5-7 years of experience in a medical device quality system (i.e., ISO 13485, 21 CFR Part 820).
- Excellent writing skills including authoring and editing operating procedures, work instructions, test plans, test cases/protocols, and test reports.
- Strong analytical and problem-solving skills, demonstrating sound judgment and understanding of strategic context with excellent attention to detail.
- Experience interacting and supporting cross-functional teams to achieve successful outcomes.
- Expertise in MS Office Suite.
- Results-oriented, positive "can-do" attitude with demonstration of appropriate urgency and initiative.
- Experience in complex computer-controlled, electro-mechanical medical devices is preferred.
- Radiation oncology device experience is preferred but not required.
Other Requirements (Travel, shift work, etc.):- Capable of working onsite at our Orange County (Irvine) location.
- Ability to travel overseas to customer installations. Current passport desired.
- Ability and desire to travel for testing activities up to 90 calendar days per year.
Physical Requirements and Work Environment:- Capable of working in safe proximity to residual radiation (with proper PPE).
- Capable of climbing steps (less than 30) around medical device.
At TAE Technologies, we consider a wide range of factors when making compensation decisions including but not limited to skill sets; experience and job-related knowledge, training; licenses and certifications, and other business and organizational needs. The total compensation package for this position may also include other elements depending on the position offered (non-Sr., Sr.,). The compensation range for these roles are $105,000 - $135,000 annually.
* Generous benefits such as Medical, Dental, Vision, 401 (K) with company match, paid vacation + sick time, companywide December holiday, wellness program, parental leave
* Payment rewards: For referring talent, novel research, and patents
* A collaborative environment: An organization where talents and interests can plug in to different groups throughout the organization
* Potential for equity participation
* HQ in Southern California
* Employee events on and off-site
* A commitment to upholding and growing an inclusive organization
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