Design Quality Engineer II

Job description

Contract (6-12 months)

Remote Work considered.

Design Quality Engineer II needed for innovative healthcare technology company based out of Snoqualmie, WA. As a key member of the Quality Engineering Team, the design quality engineer will research the objective evidence needed to support the compliance of company products to MDR requirements. The DQE provides updates to the Technical Documents file for various products as needed to demonstrate compliance to General Safety and Performance Requirements. The DQE will review with Design Control Risk Management deliverables then work with cross-functional team members to identify the evidence that is needed to address any gaps.

Email resume with "Design Quality Engineer II" in subject line to .

**RESPONSIBILITIES:**

+ Support the engineering product deliverables and the process for generating them.

+ Using established software tools, support Technical File remediation by pulling and organizing standardized documentation.

+ Clearly communicate gaps using methods that help drive the appropriate corrections.

+ Support senior level engineers with safety activities including Risk Management, Cybersecurity and Usability Engineering.

+ Support the engineering change order ECO process.

+ Support multiple projects, balancing priorities appropriately to meet both project and management expectations.

+ Support corrective and preventive action activities related to gap resolution.

**Qualifications:**

+ Bachelor s Degree in Software, Computer, Electrical or Bio-medical Engineering or other similar Technical Discipline

+ 3+ years related Engineering/Quality Engineering/Design Assurance experience

+ 1+ years Medical Device Industry

+ Detail oriented and critical thinking skills

+ Excellent verbal communication and technical writing skills

+ Ability to interface with multiple groups in the organization

Company COVID-19 Vaccine Policy To comply with applicable government requirements, all U.S. employees must be fully vaccinated against COVID-19 unless they are entitled to and approved for a legal accommodation, in accordance with the Company s COVID-19 Vaccination Policy.

**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**Why Kelly** **®** **?**

Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly® Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, we're here every step of the way to find your dream engineering job.

**About Kelly** **®**

At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.