Biomedical QA Coordinator - Process Improvement and ISO QC

Planet Pharma; Greenville (SC); On-site; USD 26,000 - 39,000; Full time

Job summary

Planet Pharma in Greenville, SC seeks a detail-oriented Quality Inspector to perform product inspections, verify design specifications, and document results according to SOPs. You will utilize metrology equipment, manage NCMRs, and support calibration records while ensuring regulatory compliance.

Ideal candidates have 5+ years in biomedical QC, familiarity with ISO 9001/13485 and 21 CFR 820 QMS, and proficiency with basic inspection tools and ERP systems like SAP.

Qualifications

• 5+ years of Quality Control experience in the biomedical industry.
• 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.).

Responsibilities

• Conduct thorough product inspections according to SOPs to verify 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 calibration programs.

Skills

Metrology inspection equipment

Microsoft Excel/Word

Problem solving

Team collaboration

Quality documentation

Education

High School diploma or equivalent

Tools

SAP or ERP system

Job description

Planet Pharma in Greenville, SC seeks a detail-oriented Quality Inspector to perform product inspections, verify design specifications, and document results according to SOPs. You will utilize metrology equipment, manage NCMRs, and support calibration records while ensuring regulatory compliance.

Ideal candidates have 5+ years in biomedical QC, familiarity with ISO 9001/13485 and 21 CFR 820 QMS, and proficiency with basic inspection tools and ERP systems like SAP.