12 days old

Remote Quality Engineer - Med Device/Orthopaedics

Kelly Services
Memphis, TN 38111 Work Remotely
**Kelly Services** is currently seeking an experienced **Quality Engineer** to work a remote contract role for the next 1.5 years! The ideal candidate will have previous knowledge of and experience with **Design Control** and have previously worked within the **Medical Device** industry.

This role will be a part of Kelly Services Project Services team so full benefits and PTO will be provided!


+ 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%


+ Bachelors degree in engineering or equivalent scientific discipline


+ 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 of experience with a Masters degree.

**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

Apply today for immediate consideration!

**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/non-traditional 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 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: 2020-11-13 Expires: 2020-12-14

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Remote Quality Engineer - Med Device/Orthopaedics

Kelly Services
Memphis, TN 38111

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