Quality Assurance Inspector

• Perform Inspection of incoming materials, components, and subassemblies
• Complete First Article Inspections upon request.
• Perform In-process and finished (sterile and non-sterile, disposable, and durable) product inspection and testing.
• Perform DHR reviews for subassemblies and finished goods.
• Conduct Product Release activities for all conforming products.
• Initiate NCR records for all non-conforming products, components, and subassemblies.
• Quarantine non-conforming product and participate in the investigation process.
• Maintain Inspection area equipment calibration and PM
• Adhere and promote GMP and GDP principles.
• Assist in external/internal audit preparations.

Requirements

EXPERIENCE/SKILL REQUIREMENTS:

• Organizational skills and attention to detail.
• Firsthand experience using measuring tools such as but no limited to calipers, micrometers, pin gauges and tensile testers.
• Ability to read and understand drawings.
• Experience working with sampling plan.
• Understanding of ISO 13485, CFR21-820, ISO 146444-1, 2 and 3.
• Able to take direction, ownership, and responsibility for QMS related activities.
• Positive and cooperative communication and collaboration with all levels to employees, contractors and vendors.
• Strong understanding of quality control standards and testing techniques.
• Electronic Quality System experience.
• Proficient with Microsoft Office, Excel, and other electronic systems.
• Medical device experience is a plus.
• Experience working a cleanroom is a plus.

EDUCATIONAL REQUIREMENTS:

• High School Diploma, GED, or equivalent with additional training in quality control in medical device industry or similar field.