CenterWatch

1+ months

Project Quality Specialist

Kelly Services
Rochester, NY 14608
**Project Quality Specialist**



Kelly Services has provided outstanding employment opportunities to the most talented professionals in the marketplace. Today, we are proud to offer an excellent contract opportunity for **Project Quality Specialist** with our client, a leader in the medical device industry, located in **Rochester, New York.**



Job overview:



Support coordination of subject matter expert assessments of standards gap assessments.



Update of product requirements to support new regulatory requirements and ensure verification and validations are complete and documented in Design History Files to support Technical File creation.



**Responsibilities:**




+ Perform Assessments of current product technical documentation vs. new EU MDR requirements and support coordination and execution of technical documentation remediation. This will include update of historical product requirements and traceability to verification and validation evidence to support new requirements and updated standards.

+ Maintain status tracking of identified gaps.

+ Supporting the Lens Care portfolio lead on MDR technical file remediation, standard gap assessments and documentation management.

+ Participate in project activities and ensure deliverables are complete to meet tight schedules.

+ Change management activities for the implementation of MDR QMS requirements.



**Requirements**




+ BS in Science field

+ 5 years experience

+ Previous experience of implementing documentation changes in Medical Device Quality Management System.

+ Cross functional project team experience

+ Working Knowledge of MS office with proficiency in Excel, Word, and Power Point.

+ Working knowledge of change management systems/processes and documentation management (Kintana & Documentum)

+ Ability to read and comprehend technical documentation

+ Ability to organize and maintain status tracking reports.

+ Strong communication skills (verbal & written) with ability to communicate with other scientific and engineering disciplines on a cross functional team.

+ Decisive, self-motivated/capable of working on own initiative, and able to prioritize with a proactive approach.

+ High attention to detail

+ Medical Device 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



**Why Kelly?**




+ As a Kelly Services employee, you will have access to numerous perks, including:

+ Exposure to a variety of career opportunities as a result of our expansive network of client companies

+ Career guides, information and tools to help you successfully position yourself throughout every stage of your career

+ Access to more than 3,000 online training courses through our Kelly Learning Center

+ Weekly pay and service bonus plans

+ Group-rate insurance options available immediately upon hire*



**Apply Today!**




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



As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping
you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ
each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.




**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: 2019-09-30 Expires: 2019-11-30

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Project Quality Specialist

Kelly Services
Rochester, NY 14608

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