IQA Technician - Inspections

the Client•Atlanta, GA

21h•Onsite

About The Position

This role supports manufacturing and testing operations adhering to Good Manufacturing Practices and Good Laboratory Practices to satisfy regulatory requirements for receiving and inspection. The technician performs all job duties in full accordance with global and technical standards and complies with Quality System (QS) requirements, ensuring parts are compliant for all parts going to the manufacturing floor and any parts going directly to the customer.

Requirements

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, ISO 13485
Good communication and computer skills, including Microsoft Word and Excel
High School Diploma or GED required
2–5 years' experience
Previous experience in Quality performing inspections
Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Nice To Haves

May operate upper-level instrumentation.
Operate 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.)
Assignments require considerable judgment, initiative, creativity, and leadership in troubleshooting, suggesting alternatives, and making recommendations for continuous quality improvement.

Responsibilities

Completes Tier 1 & Tier 2 inspections to test inbound material that will be used to assemble complex medical devices.
Performs inspection on printed material (e.g., primary and secondary labeling; manuals; print inserts; CD's; etc.).
Accepts and rejects supplier lots based on inspection results.
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 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.
Performs set-up, testing, and troubleshoots all area-specific equipment, materials, systems, and/or product.
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 SOP's, equipment, policies, and procedures, including any department-specific requirements.