Job Title: Quality Assurance Technician
Location: San Francisco Bay Area

Position Overview:
We are seeking a detail-oriented Quality Assurance Technician to support quality operations in our medical device organization. The successful candidate will play a key role in ensuring that products meet regulatory and quality standards, contributing to the delivery of safe and effective medical devices. This role requires hands-on experience with inspection, testing, and quality documentation in a regulated environment.

Key Responsibilities:

• Perform inspections and testing of incoming materials, in-process products, and finished devices to ensure compliance with specifications and standards.
• Document inspection results and maintain accurate and detailed records in accordance with company procedures and regulatory requirements.
• Assist in the calibration and maintenance of inspection tools and test equipment.
• Support non-conformance investigations, including root cause analysis and implementation of corrective actions.
• Conduct sampling and inspection following statistical techniques as required by company procedures.
• Assist in validation activities, including process and equipment validations, by gathering and recording data.
• Monitor and maintain the cleanliness and organization of inspection and testing areas.
• Support internal and external audits by providing requested quality documentation and records.
• Collaborate with cross-functional teams to address quality concerns and ensure timely resolution.
• Maintain compliance with FDA 21 CFR Part 820, ISO 13485, and other applicable standards.

Qualifications:

• High school diploma or equivalent; Associate’s degree or certification in a technical field is preferred.
• 2+ years of experience in a quality assurance or inspection role, preferably in the medical device or a regulated industry.
• Familiarity with inspection techniques, tools, and equipment, such as calipers, micrometers, and gauges.
• Working knowledge of quality standards and regulations, including FDA 21 CFR Part 820 and ISO 13485.
• Ability to read and interpret engineering drawings and specifications.
• Strong attention to detail and organizational skills.
• Basic proficiency with Microsoft Office and quality management software.
• Excellent communication skills and the ability to work both independently and as part of a team.

Preferred Qualifications:

• Experience with Class II or III medical devices.
• Knowledge of Good Manufacturing Practices (GMP).
• Experience with statistical process control (SPC) and measurement system analysis (MSA).

What We Offer:

• Competitive salary and benefits package.
• Opportunities for professional development in a growing company.
• A collaborative and innovative work environment.