Manufacturing Quality Engineer 1

Kaygen Inc.

Mebane, NC

JOB DETAILS
SALARY
$40–$45 Per Hour
SKILLS
American Society for Quality (ASQ), Analysis Skills, Biotech and Pharmaceutical, Career Development, Communication Skills, Community Support, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Documentation, Documentation Review, FDA (Food and Drug Administration), Fortune 500 Customers, GMP (Good Manufacturing Practices), Health Insurance, ISO (International Organization for Standardization), Information Technology Consulting, Maintain Compliance, Manufacturing, Manufacturing Operations, Manufacturing Systems, Manufacturing/Industrial Processes, Medical Equipment, Mentoring, Operational Support, Problem Solving Skills, Process Improvement, Process Validation, Production Systems, Quality Engineering, Quality Management, Quality Metrics, Root Cause Analysis, Startup, Trend Analysis
LOCATION
Mebane, NC
POSTED
22 days ago

KAYGEN is an emerging leader in providing top talent for technology-based staffing services. We specialize in providing high-volume contingent staffing, direct hire staffing and project-based solutions to companies worldwide ranging from startups to Fortune 500 and Managed Service Providers (MSP) across a wide variety of industries. 
Position Summary
We are hiring a junior-to-mid level Quality Engineer to support manufacturing operations within a regulated production environment.
This role will partner with production and engineering teams to address quality concerns, support investigations, improve manufacturing processes, and help ensure compliance with quality standards.

This is a hands-on role with significant presence on the manufacturing floor.

Responsibilities
  • Provide daily support for manufacturing quality activities.
  • Investigate and help resolve production quality issues and nonconforming material.
  • Support root cause analysis and corrective/preventive action activities.
  • Review production and inspection data to identify trends and process improvement opportunities.
  • Collaborate with operations, production, and engineering teams to maintain product quality and compliance.
  • Assist with containment activities, documentation reviews, and deviation support.
  • Promote adherence to quality systems, manufacturing procedures, and documentation practices.

Required Qualifications
  • Bachelor’s degree in engineering, Quality, Manufacturing, or related technical field.
  • 2–5 years of experience in a regulated manufacturing environment.
  • Knowledge of CAPA, nonconformance handling, and root cause analysis.
  • Familiarity with FDA/ISO regulated environments and GMP documentation practices.
  • Strong analytical, communication, and problem-solving skills.
  • Comfortable working extensively on the production floor.

Preferred Qualifications
  • Experience in medical device, pharmaceutical, or other regulated manufacturing industries.
  • Exposure to SPC, process validation, or manufacturing quality metrics.
  • ASQ certification or related quality training is a plus.

Work Environment
This role operates primarily within a manufacturing environment and requires extended standing/walking, use of PPE, and direct interaction with production operations.
    At KAYGEN, we are always looking for dynamic, talented and experienced individuals. We invite you to join our team of talented IT professionals, consulting at client locations across the globe. Our culture is team-orientated; we strive to stand by our core values of respect, honesty and integrity. Our team of experienced staffing experts will work with you to find you the best opportunity. For more information, please visit us at www.kaygen.com.

    Benefits:
    • Free Healthcare Insurance
    • Vision and Dental Insurance
    • 401(k) Retirement Plan
    • Free Life Insurance
    • Sick Time Off
    Achieve your Kaizen by clicking here. A unique and exclusive talent community supported by Kaygen, that includes programs like:
     
    • Certifications 
    • Mentorship Program
    • Referrals
    • Family and Wellness benefits
    • Continuous Growth and Career Development 

    About the Company

    K

    Kaygen Inc.

    Kaygen, an award-winning technology consulting and talent firm, assists organizations to achieve digital transformation. From structuring data to the Cloud and visualization, Kaygen leads the digital transformation of global clients.

    Kaygen, from the Japanese word, kaizen, for continuous improvement, signifies how we continuously seek to bring expert tech talent to our client engagements to create a sustainable competitive advantage. However, there is more. Our company is diverse, and minority woman owned and operated by expert data technologists who have conceived and developed the very strategic technology initiatives that we now engage in for our clients with our talent.

    Our core belief in diversity, complemented by the principles of kaizen, ensures we bring the best expert data talent to work transparently, collaboratively, and with the flexibility to ensure client success.

    Visit http://www.kaygen.com/ for a solutions overview.

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    COMPANY SIZE
    100 to 499 employees
    INDUSTRY
    Computer/IT Services
    EMPLOYEE BENEFITS
    Paid Sick Days, Professional Development, 401K, Employee Referral Program, Flexible Spending Accounts, Employee Events, Life Insurance, Merchandise Discounts
    FOUNDED
    2003
    WEBSITE
    http://www.kaygen.com