IQA Technician

Global Technical Talent; Irvine (CA); On-site; USD 10,000 - 60,000; Full time

Job summary

An established industry player is seeking an IQA Technician to support manufacturing and testing operations. This role involves performing critical inspections to ensure compliance with regulatory standards, utilizing advanced measurement tools, and documenting findings to drive quality improvements. You will be part of a dynamic team dedicated to advancing healthcare technology and ensuring the highest quality in medical devices. Join a forward-thinking company that values innovation and quality, and contribute to projects that make a real difference in people's lives. If you are passionate about quality assurance and eager to work in a collaborative environment, this opportunity is perfect for you.

Benefits

Medical Insurance

Vision Insurance

Dental Insurance

401k Retirement Fund

Qualifications

• 2-5 years of experience in quality inspections and measurement equipment.
• Knowledge of FDA, GMP, and ISO 13485 regulations.

Responsibilities

• Perform inspections to ensure compliance with quality standards.
• Document non-conformance and support quality management systems.

Skills

Quality Inspection

Blueprint Reading

Communication Skills

Problem Solving

Education

High School Diploma or GED

Tools

Calipers

Gauges

3D/2D Digital Measuring Projector

Optical Testing Instruments

Microsoft Word

Microsoft Excel

Job description

Job Title: IQA Technician
Contract Duration: 4 Months
Pay rate: Up to $28.16/hr
Location: Irvine, CA
Work Type: Onsite, 7 am to 3:30 pm

Job Responsibilities:

• IQA Technician supports manufacturing and testing operations, adhering to Good Manufacturing Practices and Good Laboratory Practices to satisfy regulatory requirements for receiving and inspection.
• Performs all job duties in full accordance with the client's Global and Technical standards and complies with the Client's Quality System (QS) requirements. Ensures parts are compliant for all parts going to the manufacturing floor and any parts going directly to the customer.

Completes tier 1 & tier 2 inspections to test inbound material that will be used to assemble complex medical devices:

Tier 1 inspections:

• Manual routine inspections utilizing hand tools such as calipers, gauges (ring, pin, thread, height), rulers, and visual inspections to test inbound material that will be used to assemble complex medical devices. May operate upper-level instrumentation.
• IQA Technician operates advanced upper-level instrumentation: 3D/2D Digital Measuring projector and/or Optical Testing and Visualization Instruments (e.g., Optical Gaging Product (OGP), Keyence IM, etc.)
• Performs inspection on printed material (e.g., Primary and Secondary labeling, manuals, print inserts, CDs, etc.).
• Accepts and rejects supplier lots based on inspection results. The information gathered is used by others to make both critical and strategic decisions.
• Documents the non-conformance or suspected non-conformance to standards (i.e., manufacturing documentation, material/ component specifications, operating procedures, and domestic/ international standards) through the identification of unsuccessful audits, the completion of required paperwork, system transactions, and affixing his or her mark (i.e., stamp, sign-off, or signature).
• Reviews applicable sampling plans and control plans to verify products and services conform to quality and other engineering and Quality Assurance requirements.
• Interprets drawings.
• Performs a comparison between supplier and internal measurement/inspection methods.
• Provides alternative inspection methods.
• Uses technical knowledge to acquire, analyze, and interpret data. Applies information and methods for problem solving.
• Assignments require considerable judgment, initiative, creativity, and leadership in troubleshooting, suggesting alternatives, and making recommendations for continuous quality improvement.
• Performs set-up, testing, and troubleshoots all area-specific equipment, materials, systems, and/or products.
• Supports all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, ISO or other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Adheres to all environmental, health, and safety SOPs, equipment, policies, and procedures, including any department-specific requirements.

Minimum Requirements:

• High School Diploma or GED required.
• 2-5 years' experience.
• Previous experience in Quality performing inspections.
• Experience with measurement equipment, hand tools, gages, pressure, and force gage testing.
• Training in blueprint reading and experience with inspection sampling techniques.
• Knowledge of FDA, GMP, and ISO 13485.
• Good communication and computer skills, including Microsoft Word and Excel.

Benefits:

• Medical, Vision, and Dental Insurance Plans
• 401k Retirement Fund

About the Company:
Global Healthcare Innovator
We're a leading healthcare company dedicated to improving lives worldwide. Our diverse portfolio includes medical devices, diagnostics, nutrition products, and branded generics. We're committed to developing groundbreaking technologies that address critical healthcare challenges and empower people to live healthier lives.
Join our team and:

• Work on cutting-edge projects
• Contribute to global healthcare advancements
• Experience diverse cultures and geographies
• Discover a rewarding career with a company that cares.