Medical Device QC Inspector

Your responsibilities

Position Summary:

The QC Inspector will be responsible for performing inspection on medical devices to specified requirements to determine product disposition. Will operate in accordance with company procedures, FDA Regulations, ISO 13485 and Canadian Medical Device Regulations, and other applicable requirements.

Responsibilities: Essential Duties

·         Perform mechanical, visual, packaging and document Inspection of orthopedic medical devices

·         Complete all required documentation of the inspection results, on handwritten forms, and electronic spreadsheets or databases, in accordance with company procedures and work instructions.

·         Identify and document potentially non-conforming product.

·         Ensure non-conforming product is properly segregated and quarantined.

·         Interface with other departments, to address and resolve any product related issues.

·         Assist with labeling of product and label reconciliation.

·         Perform line clearance to ensure that product integrity is maintained.

·         Read, understand, and follow company procedures and policies.

Skills and Qualifications:

·         Educational Requirements:  High school diploma/GED (Required)

o   Associate’s Degree (Desired)

·         Working knowledge of use of various gauges such as calipers, micrometers, thread gauges, etc.

·         Knowledge of quality practices, FDA Regulations and ISO 13485.

·         Knowledgeable of inspection techniques.

·         Basic understand of reading engineering drawings.

·         Good verbal and written communication skills.

·         Strong attention to detail and accurate record keeping.

·         Basic computer skills including a word processing, and spreadsheet, etc.

·         Must be flexible and able to adapt to changes in priorities.

·         Must be able to occasionally lift up to 25 lbs.