4 days old

MDR Quality Project Manager

Kelly Services
Irvine, CA 92604
Kelly is currently seeking a MDR Quality Project Manager for a long-term engagement with one of our Global Medical Device clients in Irvine, CA.

This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.

**Job Duties:**

+ Provide project leadership to transition 30 plus regulatory technical files to MDR compliant Technical Documents for submission to the Notified Body

+ Establish cross-functional project teams for each Technical Document. Identify team members and project scope

+ Create detailed Project Plan for each Technical Document to include deliverables, interdependencies, owners, and target due dates.

+ Create project kick-off presentations and lead kick-off meetings

+ Schedule and lead weekly and biweekly workstream meetings to monitor progress against Plans.

+ Publish meeting minutes including deliverable status and action items and follow-up on action items

+ Manage program budget and track expense against budget

+ Issue resolution

+ Identify project risks and escalate as appropriate

+ Maintain project and master trackers to track progress

+ Provide metrics for team presentations

+ Identify information needs, ensure information flows to appropriate functional areas, support document reviews/ approvals.

+ Maintain Program Sharepoint to provide access to project information

+ Other tasks as assigned

+ Coordinate internal resources and third parties/vendors for the flawless execution of projects

+ Ensure that all projects are delivered on-time, within scope and within budget

+ Develop project scopes and objectives, involving all relevant stakeholders and ensuring

+ technical feasibility

+ Ensure resource availability and allocation

+ Develop a detailed end to end project plan to track progress

+ Use appropriate verification techniques to manage changes in project scope, schedule and costs

+ Measure project performance using appropriate systems, tools and techniques

+ Report and escalate to management as needed

+ Manage the relationship with the execution team and all stakeholders

+ Perform risk management to minimize project risks

+ Establish and maintain relationships with third parties/vendors

+ Create and maintain comprehensive project documentation

**Desired skill sets:**

+ Excellent written and verbal communication skills

+ Excellent planning skills and ability to learn quickly, multi-task and handle multiple priorities

+ Excellent interpersonal/ influence skills

+ Excellent analytical, problem solving, process thinking skills

+ Strong computer skills with experience in Word, PowerPoint, Excel, Outlook, Microsoft Teams, (Microsoft Project is a nice to have).

+ Detail oriented

+ Can work independently and demonstrates initiative and resourcefulness

+ Drives to meet goals


+ BS degree

+ 1-3 years Quality/Compliance Experience in Medical Device

+ Min 1 year Project Management Experience

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

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**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. (
Posted: 2021-02-22 Expires: 2021-03-25

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MDR Quality Project Manager

Kelly Services
Irvine, CA 92604

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