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