Quality Engineer Job Listing at Kelly Services in Carolina, Carolina (Job ID 9413113)

Description

Kelly® Engineering is seeking a Quality Engineer for a temp to hire position at Medical Device client in Carolina, Puerto Rico. If you are passionate about shaping the world we live in and are ready to reengineer your future, trust the experts at hiring experts.

Overview
Responsible for GMP, ISO, FDA compliance as applicable during project management and transition to manufacturing, assures customer specification and inspection methods are understood and in compliance throughout engineering project into production. Responsible for auditing quality system.

Responsibilities

• Interfaces with customers along with Quality Manager to understand and communicate product requirements and inspection requirements for new and customer supplied mold projects.
• Develops and executes procedures for product and equipment Process Validations (Installation Qualification – IQ, Operational Qualification – OQ, Performance Qualification – PQ) of new and customer supplied molds.
• Coordinates, develops, and writes product and custom equipment inspection and calibration plans for new and customer supplied molds.
• Help establish and implement strong quality systems, internal auditing, supplier approval, tooling PM, facility PM program, calibration, training and CAPA program.
• Evaluates product from DOE activities to prepare for and support parametric release and quality assurance.
• Performs and documents First Article/Protocol inspections for new, customer-supplied and modified molds.

Qualifications

• Bachelor's Degree in Engineering or Related Field.
• Three to five years-experience in-process/final/raw materials inspection experience in a high-volume production environment.
• Three to five years-experience in SPC, sampling/auditing/reading blue prints/dimensioning and tolerance.
• Practical and direct experience utilizing continual improvement and quality tools to include control charts, capability studies, DOE, regression analysis, histograms and fishbone charts.
• Practical and direct experience with computer hardware and software including LAN/CIM, and statistical, graphical spreadsheets and word processing software.
• Background in corrective action and root cause analysis, preventative action and continual improvement.
• Knowledge of ISO 9001 based Quality Management Systems (QMS).
• Knowledge of ISO 13485 Medical Devices.

What happens next:
 
Once you apply, you'll proceed to next steps if your skills and experience look like a good fit. But don't worry – even if this position doesn't work out, you're still in the Kelly Engineering network. That means our team of expert engineering recruiters will have access to your profile, making your opportunities limitless.

 

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?

Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world's most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we're here to guide you to the next step in your engineering career.

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.

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