Supplier Quality Engineer Job Listing at Kelly Services in Irvine, CA (Job ID US3565140_BH9841391)

Description

Kelly Engineering is seeking a Supplier Quality Engineer for a long-term contract at 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.

This role is a full-time contract, fully benefited position.  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 Kelly employees receive annual performance reviews. 

Supplier Quality Engineer  
The individual will be responsible for supporting Cost Saving Projects. This individual will actively collaborate with Product Management, Strategic Sourcing/Procurement, Component Qualification Engineers, Quality, business partners/stakeholders, and external suppliers to support clients ' saving projects. 
DUTIES RESPONSIBILITIES : 

• Participate in and/or lead the identification, selection, qualification, monitoring, and disengagement of suppliers for Supplier Quality Management. 
• Perform due diligence assessment for selected suppliers if needed. 
• Prepare Supplier Quality Agreements and drives discussion with supplier while consulting Supplier Quality Manager. 
• Collaborate with suppliers and business partners to ensure robust materials, products, processes, and systems. 
• Partner with Procurement, R D, Engineering/Technical Operations, Quality, Operations, and Suppliers in the timely investigation, resolution/prevention of supplier-related issues. 
• Identify areas of opportunity, communicate supplier risks, and drive the resolution of supplier quality issues and risk control processes. 
• Implement supplier change management process including change notification, dissemination of information, impact assessment, approval of changes, and supports material/supplier qualifications. 
• Support component qualification in collaboration with key business partners and the supplier's applicable functional groups. 
• Comply with all applicable quality management system, environmental, safety and occupational health policies. for example, ISO 13485, ISO14001 OSHAS18001 . 
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures. 

EXPERIENCE AND EDUCATION 

• A minimum of a bachelor's degree in Engineering, an Applied Science, or a related technical and quality field is required. 
• A minimum of 3-6 years of experience in Quality Engineering or Quality Assurance, including data analysis, risk assessment and risk mitigation is required. 
• Working experience in a good manufacturing practice regulated environment, medical devices/Pharma etc. is required
• Broad experience with quality systems, including but not limited to validation, non-conformance, CAPA systems and investigations, laboratory controls, production and process controls, is required. 
• Experience with documentation and technical writing skills, in a regulated compliance environment, is required. 
• Component Qualification/Process Validation experience is preferred. 
• New product introduction experience is desired. 
• Broad knowledge of Quality System Regulations and Supplier Quality Management principles is desired. 
• Demonstrated ability to identify compliance risks and assess business impact, is required. 
• Ability to deal with complex issues using deductive reasoning, critical analysis skills and systematic approaches. 

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES

• Working knowledge of regulatory compliance requirements. Quality System Regulations QSRs, Medical Device Directive MDD, ISO 9001, ISO 13485, ISO 14971 or other international standards required. 
• Working knowledge of Quality issue investigation, Non-Conformance Reports NCRs, Corrective and Preventative Actions CAPAs preferred. ASQ Certifications for Certified Quality Engineer CQE, Quality Manager CQM, and/or Supplier Quality Professional CSQP 
• Strong analytical skills, metrics development and ability to identify trends are desirable. Knowledge of specific business practices and software applications skills Word , Excel , PowerPoint , Minitab 

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 Visa or OPT right now.

 

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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