JobWatch

22 days old

Quality Engineer - Medical Device Manufacturing

Kelly Services
Memphis, TN 38111
Kelly Services has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a temporary opportunity to work as a **Quality Engineer Medical Device** at a prestigious Fortune 500 company working in **Memphis, TN.**



This is a 12-month contract position at 40 hours per week.



**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the submit now button below to submit your resumes. If you have questions about the position, you may contact the recruiter recruiting for this position ( keig126@kellyservices.com ) however your resume must be received via the submit now button included within.


**RESPONSIBILITIES INCLUDE** :




+ Assure product design history files meet the regulatory requirements of Medical Device Regulation (MDR 2017.745), internal quality system and other applicable regulations.

+ Apply knowledge of ISO 14971 Risk Management; IEC 60601-1 Medical Electrical Equipment and collateral standards, IEC 62366 Usability, and IEC 62304 Software Lifecycle; and other applicable standards to sustaining engineering projects.

+ Serve as primary quality representative on one or more EU MDR project teams Ensure risk management documentation is updated in coordination with activities, and interfacing with project team members including engineering, regulatory, marketing, change management, post market surveillance, and production.

+ Produce technical reports to support product changes or quality assurance investigations.

+ Prepare, evaluate and critique technical documentation including design justifications and rationales based on sound scientific or engineering principles.

+ Makes decisions and proposes solutions based on calculated risks identified through data analysis.

+ Evaluate procedures and processes within the quality system to identify areas for improvement. Recommend solutions to identified problems.

+ Coordinate activities with Quality Engineering Management and report regularly on the progress of activities.

+ Participate in meeting departmental goals and objectives; on time project delivery per release project schedule

+ Travel requirement: Occasional domestic travel may be required less than 10%





**EDUCATION REQUIRED**

Bachelors degree in engineering or equivalent scientific discipline




**YEARS OF EXPERIENCE**

Preferred experience includes 4+ years at medical device company serving as a Quality Engineer supporting design control teams with a BS degree. Alternative considerations include 4+ years in Quality Assurance in a GMP environment. 2+ years experience with a Masters degree.


**QUALIFICATIONS**





**Required Qualifications**




+ Clear and concise written/electronic and verbal communication. Ability to multi-task, prioritize, meets/exceed deadlines and hold themselves accountable.

+ Self- starter, with the ability to work independently

+ Software programs - Microsoft Word, PowerPoint, Excel, Project.

+ Experience with managing documents within electronic PLM system

+ Corrective and Preventative action experience including root cause analysis

+ Experience with working with cross functional teams



Standards and Regulations




+ EU MDR 2017/745




+ EU MDD 93/42/EEC

+ ISO 13485

+ 21 CFR Part 820

+ ISO 14971

+ 21 CFR Part 820





**Preferred Qualifications**






+ Remoted working environment experience

+ Experience with Matrix PLM system

+ Experience with SAP

+ ASQ certification as a Certified Quality Engineer or Biomedical engineer

+ Six-Sigma or equivalent greenbelt certification

+ Power-BI-Data Visualization





Standards and Regulations






+ IEC 62366

+ IEC 62304














**Why Kelly** **** **?**



As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.




**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. 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, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

\#KellyGTS
Posted: 2020-10-02 Expires: 2020-11-02

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Quality Engineer - Medical Device Manufacturing

Kelly Services
Memphis, TN 38111

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast