Quality Engineer II (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 department 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 Manager 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:

• Minimal supervision: An individual will receive general guidance and oversight but is largely expected to work autonomously.

Minimum Qualifications Skills: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Education and Experience:

• Bachelor’s degree in a science or engineering discipline
• 2-10 years’ (+/- 3) experience in an engineering or quality role

Preferred Qualifications and Skills: To perform this job successfully, an individual should be able to perform each duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability preferred.

Language Ability: This position specifically requires expert-level ability to create, read, analyze, and interpret complex documents; to respond effectively to inquiries and complaints; to write problem statements, draw tightly worded conclusions, and form arguments supported by evidence for regulatory submission. Individuals who fill this role must demonstrate consistent aptitude in creating accurate, succinct documentation appropriate for both technical and non-technical audiences both by creating content and by critically reviewing content created by others.

Reasoning Ability: Root Cause Analysis will be a part of the right candidate’s skillset

Computer Skills: To perform this job successfully, an individual should be very proficient with Business Applications including, but not limited to: Microsoft Word, Excel, PowerPoint, Outlook, SharePoint, and Project. Model Based Systems Engineering (MBSE) software is a plus (Cradle, CORE, Doors); product lifecycle management tools like Arena, Omnify, or Agile.

Certificates and Licenses: CQE, CQA, SS Green Belt, SS Black Belt, RAC are all helpful

Other Skills/Abilities/Specifications: Process-oriented individual

Physical Demands and Working Environment: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

Physical Demands: While performing the duties of this job, the employee is frequently required to sit. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and talk or hear. The employee must occasionally lift and/or move up to 30 pounds. Specific vision abilities required by this job include depth perception and the ability to adjust focus.

Work Environment: Office environment, with occasional work in a lab/assembly environment

Location: On-site in Westminster, CO

Salary Range: $80K - $90K

The actual salary offered is dependent on various factors including, but not limited to, location, the candidate’s combination of job-related knowledge, qualifications, skills, education, training, and experience 

Note: Due to the nature of the work, only US Persons (citizens or permanent residents) need apply for this position. 

ALTEN Technology is an Equal Opportunity Employer. Our Policy is to extend opportunities to qualified applicants and employees on an equal basis regardless of an individual’s age, race, color, sex, religion, national origin, disability, sexual orientation, gender identity/expression or veteran status.

Please beware of job seeker scams and see this important notice on our careers page for more information about our recruiting process.