18 days old

Quality Engineer

Kelly Services
Durham, NC 27722
**Quality Engineer**

**Raleigh/Durham, NC**

**Direct Hire OR Contract-To-Hire**


The Design Quality Engineer will be responsible for assisting in the development and implementation of the quality system of the company in regards to new product development, 510(k) submissions, and customs devices.



1. Assisting in the development of the company quality system to support medical device offerings and operations and ensure continual improvement in quality. This may include drafting and reviewing quality system documents as necessary, managing document change requests, and regularly reviewing procedures for appropriateness.

2. Assisting with quality system implementation including, but not limited to:

+ Reviewing, approving, and aiding in the creation of R&D design control documents such as: Product Development Quality Plan, Design Input / Output Document, Risk Management documents such as DFMEA and PFMEA, Test Protocols and Verification and Validation Plans, and Engineering Drawing Review

+ Participating in phase review meetings

+ Mentoring R&D/Customs interns on Design Control processes for 510(k) clearances

+ Ensuring consistency across 510(k) clearance projects

+ Audit and approve custom product documentation to ensure FDA compliance using mimics

+ Continuous Improvement projects for the Design Controls system

+ Assisting in root cause investigations for process or product non-conformances

+ Contributing to design history files and other design deliverables

+ Generally assuring adherence to all company quality procedures


Bachelors degree (B.S.) in engineering from a four-year college is preferred. Preference for mechanical, biomedical, or materials science.


Experience with medical device design, testing, and clearance is a plus.

Experience with quality systems development is a plus.


Position may involve the use of:

- Basic hand tools

- Inspection and cleaning equipment


Position may involve handling of or exposure to metallic powders, mill coolant, tapping fluid, and polymeric resins.


**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, were here every step of the way to find your dream engineering job.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were 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.
Posted: 2021-11-19 Expires: 2021-12-20

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Quality Engineer

Kelly Services
Durham, NC 27722

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