Quality Control Inspector

The Quality Control Inspector ensures that our company is in continued compliance in accordance with the FDA’s QSR regulations and ISO 13485 through receiving inspection and final release.

Responsibilities

QC inspector is responsible for incoming and outgoing inspection activities for medical device parts and finished goods:

• Utilize a test instrument to complete visual, dimensional, mechanical and functional inspections of a variety of parts, assemblies or materials;
• Follow established procedures to ensure compliance with procedures, visual aids, purchased specifications, inspection forms, work orders or engineering drawings.
• Provide succinct and accurate problem identification; primarily on product, but may include process, etc.
• Document and control nonconforming product, assisting with investigation and rework throughput.
• Maintain timely training records in accordance with site training database.
• Build constructive and effective relationships throughout the organization and acts as a team player.
• Document results of all inspections in accordance with current procedures.
• Use computers to perform job duties and record information according to established procedures.
• Perform DHR (device history record) review, provide feedback and follow up for final closure.
• Review Final Inspection record and approve systems for packing.

• Perform additional tasks as requested by supervisor or manager. 

Competence and Authority

• • • Non-conforming product
    • Documentation review
    • Incoming inspection