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Quality Engineer - Remote - MDR /Contractor

Employer
Kelly
Location
Saint Paul
Salary
Competitive

View more

Quality Engineer - Remote - MDR Consultant/Contractor

Major medical device company needs updating of EU MDR and technical file transitions to present standards; totally remote role, pay to match experience.


??? Review MDD technical files and identify compliance gaps and perform mitigate to ensure successful MDR technical file submissions.
??? Perform standards gap assessments on applicable external standards and ensure site compliance.
??? Facilitate/perform mitigation on feedback from other departments/resources on technical file conversion readiness assessments.
??? Develop validation protocols; perform/coordinate appropriate testing, and author reports for shelf life studies, functional testing, chemical characterization, biocompatibility, sterilization, etc. to support MDR compliant technical files.

Qualifications/Training:
??? Proven record/experience with EU MDR 2017 and technical file transitions from MDD to MDR.
??? Foundational understanding of System Regulation, EN ISO 13485, EN ISO 14971 and EN 62366-1.
??? Familiarity/expertise in standards referenced on site standards list.
??? Familiarity/expertise in design controls and change control.
??? Working knowledge and experience with development procedures and processes, including design control.



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.

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