We use cookies to improve your experience on our site. To find out more, read our privacy policy.

Astrix Jobs

Home View All Jobs (335)

Job Information

Astrix Technology Quality Engineer II in Chino, California

Quality Engineer II

Engineering

Chino, CA, US

  • Added - 20/11/2024

Apply for Job

The Quality Engineer II will manage the Internal Audit Program, train employees as Internal Auditors, and handle failure investigations, CAPA follow-ups, supplier qualifications, and validation support. They will generate reports on key metrics (complaints, non-conformances, deviations, CAPAs) to drive quality improvements, reduce defects, and enhance efficiency.

Pay: $75k-100k/yr

Job Responsibilities:

  • Lead Continuous Improvement Projects focusing on quality processes in manufacturing and production.

  • Create, revise, and maintain SOPs as needed.

  • Conduct Process Failure Mode and Effect Analysis, investigations, and define CAPAs to prevent future issues.

  • Support validation efforts (IOQ/PQ/CS) when needed.

  • Diagnose and correct improper quality practices with guidance from Quality Managers.

  • Assist with internal audits and provide training for others to conduct area audits.

  • Maintain the CAPA program.

  • Track and analyze data to recommend improvement projects that reduce costs, defects, and inform business decisions.

  • Other duties as assigned.

Qualifications:

  • BS in Engineering or related field.

  • Experience with manufacturing, quality systems, and data analytics.

  • 3+ years in a GMP-regulated environment (preferably 21 CFR 210/211, CAPA, validation).

  • Bachelor’s degree in Engineering or related field (or equivalent experience).

  • Familiar with Microsoft Office, ERP/MRP systems, Minitab.

  • Continuous improvement experience required.

Physical Requirements:

  • Ability to lift 25+ lbs and stand/walk for extended periods.

  • Some travel (<10%).

  • Use of safety equipment in certain areas.

  • Ability to bend, push, pull, reach, and climb stairs.

INDBH #LI-DNP

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

DirectEmployers