Quality Assurance Specialist

SUMMARY:

The Quality Assurance Specialist ensures product quality by inspecting materials for conformance to engineering specifications and standards. This position involves the inspection and testing of products, materials, and components to confirm they meet established quality standards and specifications. Inspections range from covered incoming raw materials, assemblies, sub-assemblies, and finished devices. The Quality Assurance Specialist documents inspection results, identified non-conformities, and collaborates with the quality team to resolve issues and enhance processes.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Review and update Quality Management System documentation.
Review design and operations documentation to ensure compliance to Design History File requirements
Manage and organize ISO documentation for engineering change control releases
Coordinate equipment calibration program to ensure equipment meets quality requirements. Manage calibration records.
Coordinate root cause investigation activities for field returns. Feed findings into internal CAPA and continuous improvement program.
Evaluate control plans to determine optimal inspection points throughout various processes
Test and inspect products per established standards at various stages in the manufacturing process, from sub-assemblies to the final product.
Measure products with inspection equipment such as calipers, gauges, Xray, ionograph, etc.
Conduct visual inspections to identify defects according to IPC-610 soldering standards
Maintain detailed records of inspections, and present quality data to manufacturing and quality teams
Identify quality issues and product/process weaknesses to drive continuous improvement
Analyze internal and external quality data to identify trends and need for corrective actions
Collaborate with teams to identify and implement corrective actions
Report and investigate issues with purchased material and feed into Supplier Corrective Action program
Other duties as assigned

QUALIFICATION REQUIREMENTS:

EDUCATION AND/OR

EXPERIENCE:

High School Diploma or GED required. Bachelor's degree in a related field (such as Quality Assurance, Engineering, or similar discipline) preferred.
IPC-610 certification preferred.
2+ years of experience in a quality assurance role

Experience with ISO 9001 and/or ISO 13485 strongly preferred
Experience in electronic manufacturing environment with IPC-610 required
Thorough knowledge of quality control standards and testing methodologies
Experience using Microsoft Office Suite (including Excel) required.

Experience with or exposure to ERP/MRP system preferred.
Exhibits strong analytical and critical thinking abilities.
American Society for Quality (ASQ) or other relevant certifications are highly valued

PHYSICAL DEMANDS:

Lifting requirements up to 25 pounds.
Requires sitting for periods of time and occasional standing.
Use hands to finger, handle or feel.
Requires close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
Reaching required.

WORK ENVIRONMENT:

Manufacturing environment. Moderate noise level. Machinery operation requires the use of safety equipment to include but not limited to; safety glasses, hearing protection, wrist and shoe straps, and ESD smock. Loose fitting clothing and jewelry are not permitted. No food allowed in the manufacturing area. No cell phone use allowed in manufacturing area unless approved by management.

EQUIPMENT AND TOOLS USED:

Laptop computer.
Digital Multimeter
Manufacturing verification equipment and tools
X-Ray inspection
Torque drivers
Measurement devices (including ESD measurement devices)