Pay Rate: $35-$40 per hour

Location: West Hills, CA

Contract Length: 6 months with the possibility to convert or extend

This position is responsible for compliance to the non-conformance process, and to applicable Medical Device and IVD regulations and requirements by serving as a subject matter expert in providing guidance to NC owners and working closely with Material Review Board (MRB) members in the administration of NC activities and the rigorous assessment of NC documentation.

Position Responsibilities:

• Provide continuous and rigorous assessment of NC activities and documentation to assure compliance with the Quality Managment system, FDA regulations, ISO 13485, and Medical Device and IVD requirements through the review of NC records at critical phases.

• Provide guidance, support and mentorship to NC process owners regarding the NC process, best practices, record content, and software tools.

• Support MRB and senior leadership with metrics and reporting on critical aspects regarding the health of the NC process.

• Participate and coordinate MRB activities and perform walk through internal audits throughout the site.

• Support the continuous improvement of procedures, software, and training programs.

• Provide guidance in interpreting governmental regulations, agency guidelines and internal policies in general and specific to NC to assure compliance.

• Support internal and external audits and inspections for NC records and processes and other roles as needed.

• Perform other related duties as assigned.

Basic Qualifications:

• Bachelor's degree and 3+ years or Master's degree with 1+ years in a quality, manufacturing, or leadership role (preferably in Quality Managment Systems)

Desired/Preferred Qualifications:

• Experience working with CAPA, complaints, and nonconformances

• Experience in medical device, pharmaceutical, IVD and/or a comparable regulated environment

• Influence management skills; ability to work constructively across all functions of the organization as well as with external customers, notified bodies, regulatory agencies, and competent authorities

• Project management skills

• CAPA documentation systems experience (e.g. CATSWeb, MasterControl, Trackwise,, etc.)

• Experience reviewing CAPA, complaint, nonconformance documentation (preferably as an independent reviewer)

• Strong written and verbal communication skills

• Ability to educate people in the CAPA program

• Experience with quality tools and process improvement techniques

• Knowledge of effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques

• Strong analytical and decision making skills

• Understanding of FDA regulations (21 CFR 820, 210/211 as applicable and Part 11), ISO 13485, and CAPA requirements in general

#P2

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 (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly ® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s 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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s 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.