Quality Engineer I (Aerospace/Medical Devices)

We’re ALTEN Technology USA, an engineering company that provides solutions for engineering, technology, and product development projects. For decades, we’ve been helping our clients develop products that are changing the world, whether that’s by shaping the future of space exploration, saving lives with medical devices that set a new standard of care, or creating the fully autonomous electric taxi of tomorrow. Our team of more than 600 people works across industries including aerospace, medical devices and life sciences, unmanned systems and robotics, automotive OEM and tier 1 suppliers, commercial vehicle, electric vehicles, rail, and more. Our offices across the US have different industry focuses and engage with our clients in different ways, ranging from working on-site at client facilities to performing product development at our delivery centers.
 
ALTEN Group, our parent company, has been a leader in engineering and information technology for more than 30 years. ALTEN Group operates in 30 countries across Europe, North America, Asia, Africa and the Middle East and employs more than 36,000 people, 88% of whom are engineers. The company covers the whole development cycle and offers a choice of service levels, from technology consulting to complete project outsourcing.
 
When you join ALTEN Technology USA, you join a group of people passionate about collaborating to solve some of the world’s most technical engineering challenges. Our success is tied to taking care of our employees by building relationships and providing opportunities for mentorship and career growth. We offer comprehensive benefits for all full-time employees, including medical, dental, and vision insurance; a 401(k) plan with employer matching; paid time off (PTO); paid parental leave; and mentorship to help you take your career to the next level. You don’t have to take our word for it that we are a great place to work—we were named on the 2023 Top Workplaces list thanks to feedback from our proud employees.

Summary: The Quality Engineer's primary responsibility is to ensure our projects are executed according to our quality system and project plan, and that our deliverables meet our customer requirements. The regulatory and quality system requirements should be understood well by the QE, to fulfill the project requirements. The QE is responsible for ensuring that all artifacts that demonstrate the conformity of our deliverables to the project requirements have been released. The Quality Engineer also assists the Quality Manager with maintenance and updates to the quality system.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Other duties or tasks may be assigned as required. Management may modify, change or add to the duties of this description at any time without notice. The essential duties and responsibilities may include the following:

• Participate as project team members in support of Systems Engineers.
• Apply expertise in processes, standards, and tools to provide requirements interpretation and compliance design support to the product design teams and suppliers.
• Interpret relevant standards and apply risk management practices on projects in medical, aviation, and space industries.
  • Airworthiness, safety, and qualification requirements including AR4754, AR4761, DO-160, DO-178, DO-254.
  • Medical device standards and requirements including IEC-60601 and IEC-61010.
  • Consult with design engineers to provide guidance on aspects of regulatory and statutory requirements that affect design and design decisions.
• Perform requirements validation analyses for products/requirements.
• Support product configuration management and documentation compliance
• Create submission-ready, release-ready documentation.
• Review and edit content created by others to ensure that project documentation is ready for release and submission.
• Develop and lead development of test plans and procedures, conduct validation and verification (V&V) testing of requirements, and support the acquisition of test equipment and data to support V&V activities.
• In coordination with Project Managers and Systems Engineers, lead transition of designs from development into volume manufacturing.
• Support Quality department with maintenance and creation of quality system documentation.
• Adhere to ALTEN Technology Quality Management System processes and ALTEN Technology company policies.

Supervisory Needs and Responsibilities:

• Moderate supervision: Individual will receive regular direction, guidance, and feedback from a supervisor and may be required to seek approval or input before making c