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17 days old

Quality Engineer (Remote)

Kelly Services
Memphis, TN 38111 Work Remotely
In addition to your hourly rate, you will also receive 80 hours of PTO (120 hours starting year 5), 40 hours of paid sick time, 8 Paid Holidays, access to 401(k), and we pay 50% of your Health/Vision/Dental/Long & Short Term Disability Insurance.




**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 devices 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** **** **?**




The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG ) is one focus within the full array of Kelly Services workforce solutions.


Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.


The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.


**AboutKelly Services** ****




As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .


Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
Posted: 2020-11-13 Expires: 2020-12-14

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Quality Engineer (Remote)

Kelly Services
Memphis, TN 38111

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