English
French
Spanish
New Product Introduction Quality Engineer
Irvine, CA, US
Engineering
Bachelors Degree
Full Time, Temporary
$58 - $62/hr
Experienced (Non-Manager)
On-site
Biotechnology/Pharmaceuticals
First Shift (Day)
Irvine, CA, US
$58 - $62/hr
Experienced (Non-Manager)
Full Time, Temporary
Biotechnology/Pharmaceuticals
On-site
Engineering
Bachelors Degree
First Shift (Day)
Job details
New Product Introduction Quality Engineer
- Location: 100% ONSITE – Irvine, California (92618)
- Type: 6 months
- Pay Rate – Negotiable depending on DIRECT-related experience UP to $58/hr – $62/hr
- Work Authorization – Must be currently in the United States with active employment authorization documents without CURRENT sponsorship transfer requirements
Job Summary:
The regional NPI QE team as part of GQO Quality Assurance organization with responsibility for quality assurance activities, including, but not limited to the following:
Key Accountabilities – NPI QE Standard Work
- Collaboration with R&D, AO & GQO throughout the NPI and overall product lifecycle
- Drive Process Risk Management activities
- Develop Effective Inspection processes
- Validation Quality Approver and, where certified, Validation Rep/Specialist
- Drive Process Excellence, pursuing validation over verification, where appropriate
- Own the NPI Purchasing Controls via PPAP and related efforts
Design Transfer (in aggregate):
- Design and Process Transfer, Project Transfer
General Responsibilities
- Foster collaborative internal/external professional relationships across Design Divisions, Advanced Operations & GQO functions associated with design transfer activities.
- Communicate effectively with all internal customers, stakeholders, and project teams to deliver successful project transfers with the highest levels of quality that meet the NPI project goals.
- Mentor other groups on areas of expertise with particular attention to design and process transfer.
Risk Management
- Effective in risk management practices and tools, having high expertise in failure modes associated with production and production related processes, (PFMEA).
- Support the Risk Management File through risk Management Principles.
- Responsible for the evaluation of process risks, risk mitigation and ensures appropriate production and process controls are identified, qualified, and implemented throughout the product manufacturing lifecycle.
- Ensure all Risk Management outputs comply with ISO 14971.
- Support Design team to complete CQA/CTQ identification and inputs to dFMEA.
Inspection
- Implement lean inspection strategies and inspection plans through state-of-the-art inspection methods and technologies.
- Ensure inspections are repeatable, efficient, and scalable.
- Lead continuous improvements of inspection methods and sampling plans, with a focus on human error risk elimination.
- Lead First Article Inspection (FAI) Strategies, both internally and externally, and approve First Article Inspections.
- Optimize inspection costs through lean initiatives while maintaining safety, integrity, and reliability of the product.
Must haves:
- Collaboration with R&D, AO & GQO throughout the NPI and overall product lifecycle
- Ability to drive Process Risk Management activities
- Development of Effective Inspection processes
Nice to haves:
- Validation Quality Approver and, where certified, Validation Rep/Specialist
- Drive Process Excellence, pursuing validation over verification, where appropriate
- Own the NPI Purchasing Controls via PPAP and related efforts
Education:
- B.S. in Engineering, Physical Sciences or Statistics. M.S., in the same disciplines, preferred.
- 3 years of professional experience, minimum, post academia.
*** Kelly does not expense relocation/interview costs. ***
Important information: To be immediately considered, please send an updated version of your resume to Deas172@kellyservices.com.
10326348
I want more jobs like this in my inbox.
Similar Jobs
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 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.
Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice.