Design Quality Engineer

Tri Alpha Energy Inc.; Irvine (CA); On-site; USD 105,000 - 135,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with company match

Unlimited vacation + sick time

December holiday

Wellness program

Parental leave

Job summary

TAE Technologies in Irvine, CA is seeking a Quality System professional to own design controls documentation, verification and validation activities for our medical device program. You will train on QMS docs, maintain procedures, and support cross-functional teams.

The role requires a BS in a technical field and 5–7 years in medical device quality systems (ISO 13485, 21 CFR Part 820), strong writing, problem solving, and MS Office expertise.

Qualifications

• Bachelor's degree (BS) in technical or life science field.
• Minimum of 5-7 years of experience in a medical device quality system (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.

Responsibilities

• 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

Skills

Technical writing

Analytical skills

Cross-functional collaboration

MS Office

Problem solving

Regulatory experience

Medical devices

Detail-oriented

Education

BS in technical or life science

Tools

MS Office Suite

Job description

Copernicus Office TLS

9750 Irvine Blvd

Irvine, CA 92618, USA

Copernicus Office TLS

9750 Irvine Blvd

Irvine, CA 92618, USA

TAE is the world’s first private fusion energy company, founded in 1998 to commercialize the cleanest, safest, most affordable, and sustainable form of carbon-free power. We are applying science and engineering to design transformational technologies. Whether it's harnessing fusion through the science of stars, making exponential leaps in power efficiency, or innovating medical care with a novel cancer treatment: We're turning the promise of science into reality.

We’re looking for candidates who are passionate about realizing our mission: A future where all people have affordable access to reliable, abundant, and environmentally friendly fusion-generated electricity.

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.

Imagination, skill, and will

We are a diverse team of over 500 engineers, scientists, professionals, Maxwell Prize winners, and big thinkers from more than 40 countries with a track record of delivering on the innovative ways science can lead humanity into a brighter era. We are not afraid to envision a future where fusion and science can transform our world.

What you’ll get with us

• Generous benefits such as Medical, Dental, Vision, 401 (K) with company match, unlimited vacation + sick time, companywide December holiday, wellness program, parental leave
• 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

TAE Technologies is an Equal Opportunity Employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.

We ensure all individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us [e-mail] to request accommodations or request more information.

Note to Agencies

TAE prefers to hire directly and maintains an existing preferred supplier list. We do not accept speculative CVs or referrals from agencies. If speculative CVs are sent, no fee will be applicable.

Qualifications

Skills

Behaviors

Motivations

Education

Experience

Licenses & Certifications

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.