R&D Quality Documentation Specialist

Job Description

Job Description

Kelly Engineering is seeking an R&D Specialist - Quality Documentation Coordinator for a long-term contract with one of our Global Medical Device clients located in Irvine, CA .

Our Client is a global leader in the science of diagnosing and treating heart rhythm disorders. The company partners with clinicians to develop innovative technologies that improve the quality of care for arrhythmia patients worldwide

As a Kelly employee, you will be eligible for Medical & Dental 50% paid , 401K, and a variety of other benefits to choose from.   You will also be eligible for paid time off, including holiday, vacation and sick/personal time.  All KellyOCG employees receive annual performance reviews.

R&D Specialist - Quality Documentation Coordinator
This position is a specialist in supporting project teams in the development of electrophysiology catheters and/or related accessories. The project coordinator works directly with the team to coordinate activities related to new product development and the lifecycle. This can include, but is not limited to, sourcing engineering materials for new product development, managing the supply chain for new product materials, controlling inventory, and design control for new product development build activities from inception to submission. Coordinate essential R&D tasks that include contracts with HCPs, training team associates, travel for HCC professionals and other R&D visitors, budget tracking and accruals per finance needs.

Key Responsibilities and required qualifications

• Manufacturing line support and DHR audit experience
• Being a self-starter is important in this role
• Lead the execution, audit, and closure of work orders
• Function as Project Coordinator for the Device History File of a project team
• Manage the supply chain for new product development materials
• Manage inventory of new product development materials
• Kit materials for new product development builds while maintaining traceability
• Maintain design control for new product development build activities
• Supports project team/ technical projects and initiatives that focus on cost improvement, business continuity, process excellence to enable product development activities
• Support Compliance activities
• Responsible for coordinating and tracking training for team associates
• Monitor and report on project budget expenses
• Support the project team in the creation and reconciliation of purchase order requisitions
• Monitor and report on budget spend in anticipation of quarterly and fiscal year close
• Coordinate logistics and payment for physician engagements and project studies
• Coordinate requests for HCP & non-HCP engagement, travel, and research contracts
• Supports projects/ initiatives to enable product development activities

Required

• Medical device experience is required
• Manufacturing line support and DHR audit experience
• In-depth knowledge of MS Office (i.e. Excel, Word, Outlook, and PowerPoint)
• Knowledge of PLM systems (i.e. JDE, Windchill)
• Ability to work with internal engineers & external vendors, detail-oriented to track progress
• Excellent verbal and written communication skills
• Exceptional aptitude in multitasking
• In depth understanding of specialized area to support new product development and lifecycle management (Product structure, Bills of Material, routings, etc.)
• Decision-making ability
• Self-motivated and project-oriented, whether independently or with a team
• Good sense of urgency
• Strong technical skills are required
• Knowledge and experience in product development processes a plus
• Locate sources for engineering materials and services, obtain quotes and place orders for material and services
• Support communication activities regarding R&D initiatives
• Some program management duties as assigned

Experience and Education

• A Bachelor’s Degree in a relevant field and 4-6 years’ related work experience
• Associates Degree with 6+ years’ experience

Important information:  This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States immediately and without employer sponsorship.  Not accepting C2C, H1B Visas

 

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Engineering/Technology - Project Services?

Looking to work with leading project management organizations at top companies around the world? That’s where we come in. At Kelly Engineering and Kelly Technology, our Project Services Teams create expert talent solutions to solve the world’s most critical challenges. We connect you with opportunities to work on intriguing, innovative, and high-visibility projects-all with a schedule that works for you. Do you prefer the variety and flexibility of short-term projects? Or are looking for a long-term opportunity? Either way, our connections and expertise will help you take your career exactly where you want to go. That’s just good planning.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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