Quality Control Inspector I

Quality Control Inspector I – Day Shift
Schedule: Monday–Thursday, 6:00 AM – 2:30 PM | Friday, 5:00 AM – 1:30 PM

Location: San Jose, CA

Type: Full-Time | Temp-to-Hire

Position Overview:
A leading manufacturer of precision medical products is seeking a Quality Control Inspector I to support inspection and testing operations for disposable devices and related components. This role is responsible for ensuring adherence to product quality standards through in-process and final inspections, documentation, and support of nonconformance investigations. Attention to detail and a strong understanding of Good Documentation Practices (GDP) are essential.
You will be part of a quality-focused team in a regulated environment, contributing to product reliability and safety.

Key Responsibilities:

Perform in-process and final inspections of disposable medical components

Accurately record inspection data in compliance with GDP and regulatory requirements

Utilize measurement tools including calipers, micrometers, microscopes, and flow meters

Support investigations into nonconformances and assist in corrective actions

Maintain compliance with internal quality systems and applicable standards (e.g., ISO 13485)

Follow all workplace safety and cleanroom protocols

Collaborate with team members to ensure continuous quality improvement

Qualifications:

2+ years of experience in quality control or inspection in a manufacturing environment (preferably medical device or regulated industry)

Working knowledge of ISO 13485:2016 and quality system regulations

Proficient in the use of common inspection tools and equipment

Comfortable working independently with minimal supervision

Able to read and interpret technical documents, work instructions, and diagrams

Strong written and verbal communication skills

Detail-oriented with a focus on accuracy and traceability

Physical Requirements:

Must be able to sit, stand, kneel, or move within the facility as required

Ability to work in a cleanroom environment, sometimes on knees for extended periods

Occasionally lift or move items weighing up to 15 lbs

Work Environment:

Primarily cleanroom-based with controlled temperature and air quality

Occasional exposure to moderate noise levels from manufacturing or testing equipment

Personal protective equipment (PPE) provided and required as needed]