QC Technician - Medical Devices

The QC Technician will conduct device component receiving, in-process, and final inspections, including production and R&D items, according to the company's standards operating procedures (SOPs) and drawings. Duties of the QC Technician include:

• Testing components for incoming inspection, in-process and final inspection. 
• Assist in keeping records of inspections in compliance with quality procedures for internal and external audits
• Assist the QA / RA Director activities: audits, MRB, CAPA, etc.

Key Responsibilities:

• Monitoring accurate testing and inspection SOPs.
• Reports to QA/RA manager on deviations from SOPs and instructions and participate in corrective actions as needed.
• Assist in keeping records of inspections.
• Assist in initiating action to prevent the occurrence of any nonconformities relating to the product, process and quality system.
• Assist the QA / RA Director activities: audits, MRB, CAPA etc.

Skills & Requirements:

• Ability to read, understand, and precisely follow company standard operating procedures and supervisor instructions
• Mechanics and Optics quality control experience of at least five years
• Good background and training in ISO 13485 and 21 CFR Part 820 requirements
• Good hand/eye coordination for working with small articles and measurement devices under magnification
• Excellent (corrected) near visual acuity
• Precise and accurate recording of inspection data
• Clear, legible handwriting
• Trustworthy and quality-oriented
• Good communication skills
• Able to work independently and as part of a team