Quality Lab Tech: Precision Testing for Med Devices

Lincotek Group; Tennessee; On-site; USD 42,000 - 68,000; Full time

Job summary

Lincotek Medical in Tennessee seeks a Quality Lab Technician who will analyze, test, and document results for product release, ensuring reliability and compliance.

You'll perform material and finished product testing, review procedures, maintain calibration records, and support investigations into non-conformances. Strong attention to detail and data analysis are essential for this role.

Qualifications

• High school diploma or equivalent required.
• Knowledge of ISO 13485 and FDA CFR requirements preferred.
• Experience with tensile testing, XRD, and lab inspections is a plus.

Responsibilities

• Analyze, perform testing, and generate documentation for product release.
• Follow lab sampling procedures and record quality data.
• Review and revise LAB/SOP procedures.
• Review lab systems efficiency for inspections.
• Test materials and products to ensure finished product quality.
• Assist in investigations of customer complaints and non-conformances.
• Coordinate with suppliers for lab sample testing and PO requests.
• Schedule and maintain clean room verification audits.
• Maintain calibration history and ensure tools calibrated.
• Perform verifications on handheld inspection instruments.
• Schedule calibration services with approved contractors.
• Perform XRD testing on powdered hydroxyapatite following SOPs.
• Perform standard tensile, shear, and metallographic testing per ASTM.
• Participate in MRBs for nonconforming materials.
• Assist compliance with quality/regulatory requirements.
• Inspect purchased parts per criteria and document nonconformance.

Skills

Attention to detail

Communication skills

Data collection & analysis

Problem solving

Planning & organizing

Teamwork

Time management

Education

High School Diploma or equivalent

ISO 13485 knowledge

FDA CFR knowledge

Tools

SAP knowledge

MS Office

SPC Charting

Job description

Lincotek Medical in Tennessee seeks a Quality Lab Technician who will analyze, test, and document results for product release, ensuring reliability and compliance.

You'll perform material and finished product testing, review procedures, maintain calibration records, and support investigations into non-conformances. Strong attention to detail and data analysis are essential for this role.