QA Coordinator

Job Description

Duties and Responsibilities:

• 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.

Education and Experience:

• High School diploma or equivalent.
• 5+ years of Quality Control experience in the biomedical industry.
• Experience with Metrology Inspection Equipment.
• Experience with SAP or similar ERP systems.

Knowledge, Skills, and Abilities:

• 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.