Quality Technician II

About the role

The Quality Technician II supports and executes quality assurance activities across manufacturing and development, focusing on complex tasks. This role works closely with Quality Engineers and cross-functional teams to ensure compliance with internal procedures and external regulations.

Responsibilities

• Independently perform and document qualification and validation activities (IQ, OQ, PQ) under Quality Engineer (QE) guidance.
• Lead efforts in statistical analysis and trending to assess process capability and identify areas for improvement.
• Validate and implement inspection procedures and test methods with limited QE oversight.
• Manage the Calibration and Environmental Monitoring programs, including vendor communication, out-of-tolerance investigation, and trend reporting.
• Review, approve, and troubleshoot nonconforming material reports; assist in determining root cause and driving disposition decisions.
• Lead Device History Record (DHR) reviews and provide quality review training to new staff.
• Support and facilitate CAPA investigations; assist in effectiveness checks.
• Identify and lead continuous improvement initiatives within the quality function.
• Participate in and occasionally lead Gemba walks, 5S, and internal audits.
• Collaborate with cross-functional departments including Manufacturing, R&D, Regulatory, and Engineering.

Requirements

• High School diploma or equivalent required; associate degree or technical certification preferred.
• 2+ years of quality experience in a manufacturing environment, preferably in the medical device industry.
• In-depth knowledge of 21 CFR Part 820, ISO 13485, and other applicable quality system regulations.
• Demonstrated experience with inspection techniques, statistical analysis tools, and quality documentation systems.
• Proficiency in Microsoft Office and ERP/MRP systems.
• Strong written and verbal communication skills.
• Excellent attention to detail, time management, and organizational skills.
• Ability to independently solve problems, manage tasks, and support multiple priorities in a dynamic environment.

Qualifications

• Experience with CAPA, risk analysis, validation, and calibration programs is highly desirable.

Skills

• Quality Assurance
• Statistical Analysis
• Inspection Techniques
• Process Improvement
• Document Management
• Microsoft Office
• ERP/MRP Systems

Benefits

• Training and career development
• Healthcare and well-being programs including medical, dental, vision, wellness, and occupational health programs
• Paid Time Off
• 401(k) retirement savings with a company match

Pay

$24 to 34/hr depending on skills and experience.

Schedule

N/A

Benefits

• Training and career development
• Healthcare and well-being programs including medical, dental, vision, wellness, and occupational health programs
• Paid Time Off
• 401(k) retirement savings with a company match