QA Coordinator (Quality Assurance Coordinator)

Job Description Summary:

Duties:

• Conduct thorough product inspections according to Standard Operating Procedures (SOPs) to verify compliance with design specifications
• Perform incoming material inspections using vision inspection systems such as Keyence
• Generate Non-Conforming Material Reports (NCMRs) for products or materials that fail to meet specifications
• Create, maintain, and organize inspection records and retain samples according to quality protocols
• Proactively identify and recommend process improvements through critical thinking and problem-solving
• Verify test equipment and tools are properly calibrated according to established calibration programs
• Perform additional quality-related activities as assigned by management

• Experience with Metrology Inspection Equipment
• Experience with SAP or similar ERP systems
• Knowledge of ISO 9001:2015 / ISO13485:2016, 21 CFR 820's QMS

• Proficiency with basic inspection tools (Calipers, Gauges, etc.)
• Strong problem-solving, critical thinking, and organizational skills
• Excellent written and verbal communication abilities
• Proficient in Microsoft Excel, and Word,
• Ability to work collaboratively in a team environment
• Physical ability to lift and/or move up to 50lbs

• High School diploma or equivalent
• 5+ years of Quality Control experience in the biomedical industry.

English

Read

Required Skills

• PRODUCT INSPECTIONS
• INCOMING MATERIAL INSPECTIONS
• VISION INSPECTION SYSTEMS
• KEYENCE
• NON-CONFORMING MATERIAL REPORTS (NCMRS)

Additional Skills

• INSPECTION RECORDS
• METROLOGY INSPECTION EQUIPMENT
• SAP
• ERP SYSTEMS
• ISO 9001:2015
• ISO13485:2016
• 21 CFR 820'S QMS
• BASIC INSPECTION TOOLS
• MICROSOFT EXCEL
• WORD
• CRITICAL THINKING
• PROBLEM-SOLVING
• ORGANIZATIONAL SKILLS
• WRITTEN AND VERBAL COMMUNICATION ABILITIES
• WORK COLLABORATIVELY IN A TEAM ENVIRONMENT

English( Speak, Read, Write )

Completed High School (Diploma or GED)