Quality Engineer Job Listing at Kelly Services in Santa Fe Springs, CA (Job ID US3541884_BH9753392)

Description

Position: Quality Engineer
Type: Direct Hire
Location: Santa Fe Springs, CA
Salary Range: $80K-$90K (Based on Experience)

SUMMARY
Kelly Engineering is seeking a Quality Engineer for a direct hire role with our client in Santa Fe Springs, CA. In this position, you will support manufacturing and work cross-functionally to resolve technical problems. Participate in decisions on scope of work, risk management, process changes, process improvements, material disposition, and implementation of corrective and preventative actions. Support or provide solutions to broad problems. Develop protocols for design, and process activities (including those related to verifications or validations), determine criteria and generate summary (or final) reports.

RESPONSIBILITIES

• Collect, analyze, and present data using statistical methods to support quality decision-making.
• Utilize quality tools to drive continuous improvement, including process flowcharting, Pareto analysis, correlation and regression analysis, significance testing, design of experiments (DOE), statistical process control (SPC), gage repeatability and reproducibility (GRR), and trend analysis.
• Assist in the development and execution of key QMS deliverables, including
• Advanced Product Quality Planning (APQP), complaint analysis, risk analysis, Failure Mode and Effects Analysis (FMEA), Corrective and Preventive Actions (CAPA), and process/equipment/software verification and validation.
• Plan and/or conduct process and equipment validations, including Installation
• Qualification (IQ), Operational Qualification (OQ), and Performance Qualification
• Support process capability assessments by planning and executing Process Capability studies.
• Monitor engineering production processes and products to ensure compliance with both internal and external quality standards.
• Recommend modifications to improve quality and optimize production within equipment capabilities.
• Track and analyze key performance metrics to assess and improve operational performance.
• Collaborate with cross-functional teams to address production and quality issues with minimal supervision.
• Maintain adherence to QMS procedures, work instructions, and forms to support quality and regulatory compliance.

QUALIFICATIONS

• Bachelor's degree in engineering, life science or other technical discipline.
• 3+ years in quality assurance working in a medical device/pharmaceutical manufacturing environment.
• FDA (CFR 820, 210 and 211), and ISO 13485 quality management systems experience.
• Knowledge of statistics and Minitab, including process capability and data normality assessments, analysis of variance, hypothesis testing, determining appropriate sample sizes, tolerance interval assessments for variable and attribute data, design of experiment (DOE), and variable and attribute sampling plan applications
• Strong analytical abilities to identify, articulate, research, gather data, and solve problems by making informed decisions based on available information.
• Exceptional technical writing skills, with the ability to create and update internal and external documentation as well as author technical reports.
• Demonstrated ability to thrive in high-pressure environments requiring a strong sense of urgency, analytical problem-solving, and interpersonal skills. Capable of managing multiple complex tasks simultaneously while excelling as a team leader, member, and independent contributor.
• Excellent verbal and written communication skills, with the ability to clearly present and justify quality requirements.
• Strong attention to detail, ensuring precise measurements, accurate documentation, and thorough review of quality records.

PREFERENCES

• ASQ Certified Quality Engineer (CQE) or equivalent RA/QA certification in regulated healthcare products.
• Statistical Process Control (SPC) and Lean Six Sigma training.
• Process Failure Modes and Experience with the application of ISO 14971 for process FMEA and process validations (IQ/OQ/PQ) to mitigate risks.

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. 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.

 Apply on company website