Quality Technician II (Contract)

Cirtec Medical; Santa Clara (CA); On-site; USD 28,929 - 56,481; Full time

Benefits offered by this job

Training and development

Healthcare and well-being programs

Paid Time Off and 401(k) retirement

Job summary

Cirtec Medical is seeking a contract Quality Engineer to assist QA, QC and Manufacturing engineers in resolving production quality issues. This role will perform IQ/OQ/PQ activities, lead CAPA investigations, and help maintain device history records.

The position focuses on process improvement, statistical analysis, calibration programs, and internal audits. This is a 3-6 month assignment that offers hands-on experience in a medical device environment.

Qualifications

• 2–3 years of quality experience in manufacturing, preferably medical devices.
• Familiarity with IQ/OQ/PQ and calibration programs.
• Experience with CAPA, risk analysis, and quality documentation.
• Strong written and verbal communication skills.

Responsibilities

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

Skills

Quality engineering

Analytical thinking

Communication skills

Problem-solving

Attention to detail

Education

High School diploma or equivalent; associate degree or technical certification preferred

Tools

Microsoft Office

ERP/MRP systems

Job description

Description

About us:

For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems.

Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenges, you may be a perfect fit for our team!

This role is a 3-6 month contract role.

Position Summary

This position is primarily responsible with assisting quality engineers, quality control, and manufacturing engineers in resolving quality issues in production. Individual responsibilities to be assigned at the discretion of the Quality Manager.

Key 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.

Must Have

• High School diploma or equivalent required; associate degree or technical certification preferred.
• Minimum 2-3 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.
• Experience with CAPA, risk analysis, validation, and calibration programs are highly desirable.

Salary Range is $35/ hour.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec's goal to create a great work environment and to keep the company a great place to work.

We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Benefits

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