Quality Engineer I (Aerospace/Medical Devices)

Job Description

**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 certain decisions or taking specific actions.

**Minimum Qualifications and 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.

* Bachelor's degree in a science or engineering discipline
* 0-2 years' 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 environment

**Location:** On-site in Westminster, CO

**Salary Range: $70K - $80K**

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.