JobWatch

1+ months

Quality Engineer

Kelly Services
Jacksonville, FL 32232
Kelly Outsourcing & Consulting Group (KellyOCG), a managed solution provider and business unit of Kelly Services, Inc., is currently seeking a Quality Engineer for a project engagement at one of our Global clients in Jacksonville, FL. This role is a full-time, fully benefitted position. As a KellyOCG employee you will be eligible for Medical, Dental, 401K and a variety of other benefits to choose from. Youll also be eligible for paid time off, including holiday, vacation and sick/personal time. All KellyOCG employees receive annual performance reviews.


As a Quality Engineer placed with KellyOCG you will be responsible for the following:

Position Summary:

PMS Report Maintenance during Transition to EUMDR.

Maintenance Includes:

? Completion of PMS Reporting for all product for 2021 and 1H2022.

? Completion of PMS Reports for Class 1 Devices, Non-CE Marked Devices.

? Maintaining PMS Reporting schedule in alignment with CER and PSUR Schedule.

? Verifying registration status of products for PMS Reporting Schedule. o Undergoing document control process

? Uploading documents to Agile / submitting CO ? Working with Doc Control to complete DCRB review / outstanding items on CO

? Following up on approvals

Assist PSUR Team in the following activities to support PMS Reporting and Complaint Trending Process:

PMS Plan Maintenance o Manage: JJSV 82 MDR Complaint Plans (covering ~140 products), JJVC - ~ 7 MDR Compliant PMS o Maintenance includes: keeping in contact with business partners to keep track of entire product portfolio and be aware of any changes.

? New Products / Obsoletions

? Change of Registration Status (EU, Canada, etc.) Vision EU MDR Contractor Resources HC Approval Form Template - Vision EU MDR Contractor Resources HC Approval Form(PMS_Allison ballard).docx

? Update to Safety Classification as a result of recall / PSUR or PMSR outcome

? Change to product data sources

? PMS Plan Template Revisions o Undergoing document control process

? Uploading documents to Agile / submitting CO

? Working with Doc Control to address outstanding items on CO

? Following up on approvals

QMS Documentation / Administration o PMS and Complaint Trending procedure updates as a result of evolving knowledge of Notified Body / Competent Authority understanding/implementation of MDR Regulation. Adapt existing procedures to emerging guidance / reference material from NB or HMD o Procedural redlines pertaining to audit observations, near misses and overall PMS System improvement o Undergoing document control process

? Uploading documents to Agile / submitting CO

? Working with Doc Control to complete DCRB review / outstanding items on CO

? Following up on approvals

Continued PSUR Support o Support to maintain PSUR Cadence (on time completion of reports) o Following up with business partners on data requests o Maintaining minutes for ongoing business partner meetings ? Capture crucial highlights to reenforce understandings/decisions made at meetings

? Action items including administrative follow-ups o Undergoing document control process


Technical Degree required

3-5 years experience


**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: 2022-06-29 Expires: 2022-08-29

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Quality Engineer

Kelly Services
Jacksonville, FL 32232

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