Staff Development Quality Engineer Location: Onsite - Miami, Florida (33196)
Type: Contract - (NO C2C OR THIRD PARTY)
Duration: 12 + months - Opportunity for contract extension
Pay Rate – Negotiable depending on DIRECT-related experience
Work Authorization - Must be able to work in the U.S. with approved authorization
The Staff Development Quality Engineer supports new product development (instruments, reagents, consumables, and software) from a QA perspective. The primary role of the position is to provide guidance and direction to cross functional core teams to meet design control requirements in support of market release of new products. The position also supports post-launch design changes for fielded products.
RESPONSIBILITIES: Provide strategic direction for new product development and design change teams in terms of quality functions including design quality, manufacturing quality, process validation, supplier quality, post-market quality and risk management.
Ensure proactive compliance to all applicable internal, domestic and international regulations including US 21 CFR 820 (QSR), ISO 19471:2019 and ISO 13485:2016.
Ensure compliant and complete product documentation, inclusive of DHFs, with particular focus on design controls, risk management and document controls.
Lead extended Quality teams for new product development and design change projects.
Responsible for Design History File (DHF) completeness and maintenance.
QUALIFICATIONS: Bachelor's degree in engineering or science discipline with seven years of experience in a regulated environment or master's degree in engineering or science discipline with five years of experience in a regulated environment.
Experience in application of design controls in accordance with 21 CFR Part 820, ISO 13485, and ISO 9001 for the development of products and design change.
High level of autonomy and critical thinking is required. Teamwork oriented.
ASQ Certified Quality Engineer (CQE) is preferred.
Important information: To be immediately considered, please send an updated version of your resume to .
#ISO13485
#21CFR
#DesignHistory
#DesignReview
#RiskManagement
#SoftwareVerification
#CQE
#RegulatedIndustry
#ProcessValidation
#SupplierQuality
Design Control 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.
