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Quality Control Technician

Astrix Technology • Lake Forest, CA • 3w ago

Quality Control

Lake Forest, CA, US

Pay Rate Low: 26 | Pay Rate High: 26

Added - 02/04/2025

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Are you detail-oriented with a passion for quality and compliance? Do you thrive in a hands-on environment where accuracy and problem-solving are key? If so, this opportunity is for you.

Pay : $26/hr

What You'll Do :

Ensure accuracy and compliance by verifying and logging incoming electromechanical devices, making sure they align with return policies and criteria.

Maintain sample integrity by tracking and processing customer returns, keeping thorough records from intake to final disposition.

Investigate and troubleshoot returned devices, performing hands-on analysis and documenting findings in sample investigation logs.

Manage lab operations by overseeing equipment calibration, preventative maintenance, and material purchases to support investigations.

Collaborate across teams, including Quality, Manufacturing, R&D, Supply Chain, and Finance, to drive product and process improvements.

Ensure regulatory compliance with FDA regulations, ISO 13485 standards, and global medical device quality requirements.

What We're Looking For :

Experience: 1-3 years handling material intake, preferably within medical devices or a regulated industry.

Technical Skills: Strong computer proficiency in Word and Excel, with familiarity in medical device complaint files and quality records.

Regulatory Knowledge: Understanding of FDA regulations (21 CFR Part 820 & Part 803) and ISO 13485 standards.

Education: High school diploma or GED required; associate's or bachelor's degree preferred.INDBHThis job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

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.

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