Quality Control Technician

Quality Control Technician at ClinLab Solutions Group Quality Control Technician at ClinLab Solutions Group in Richboro, Pennsylvania Posted in 7 days ago.

Type:

full-time

Job Description:

Work Location:

Bucks County, Pennsylvania Summary:

The Quality Control Technician is responsible for testing and evaluating finished devices, printed circuit board assemblies, and mechanical/electronic sub-assemblies. This role involves reviewing records, ensuring compliance with documentation standards, and supporting product release processes.

Responsibilities:

Perform inspections and testing at various production stages, including incoming, in-process, and final product checks. Evaluate printed circuit board assemblies for defects such as solder quality and visual damage. Review and verify production and quality records to ensure compliance with acceptance criteria and documentation standards. Manage batch record systems, including data collection, closure, disposition, and archiving of records. Log batch record data into quality metrics databases and generate reports on yields and defects. Support defect tracking and product acceptance processes, escalating discrepancies as needed. Utilize measurement tools such as multimeters, calipers, and micrometers for quality assessments. Collaborate with team members to maintain compliance with regulatory and quality management requirements.

Qualifications:

Associate's degree in a science or technical field, or high school diploma with relevant work experience. Minimum of 2 years of experience in a QA or QC role within medical device manufacturing or a related industry. Experience with manufacturing quality record review is strongly preferred. Direct knowledge of Good Documentation Practices (GDP) and quality management systems. Familiarity with regulatory compliance requirements such as FDA Quality System Regulation and

ISO 13485

is preferred. Experience with PCB assembly and/or electronics manufacturing. Proficient in Microsoft Office Suite (Word, Excel, PowerPoint). Strong organizational skills, attention to detail, and ability to manage multiple priorities independently. Excellent communication and interpersonal skills. Experience using measurement tools including multimeters, calipers, and micrometers. Ability to use standard office equipment (computer, mouse, keyboard, printer, etc.). Advanced fine motor skills and specific vision abilities (close vision, color vision, peripheral vision, depth perception, and focus adjustment). Must be able to lift up to 30 lbs.

Published Category:

Quality & Validation