Lincotek Memphis Quality Lab Tech (in AOP)

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, headquartered in Rubbiano, Parma, Italy, is a global contract manufacturer for services in markets including Industrial Gas Turbines, Aerospace and Medical Device applications, as well as a leading manufacturer of industrial coating equipment and one of the most respected producers in the Additive Manufacturing field. The Group has more than 1,800 employees located in 18 production facilities across Europe, North America and Asia.

Position:

Analyze, perform testing, and generate documentation with results for product release. Responsible for ensuring results meets the established standards of quality including reliability, usability and performance as required by the customer and standards. Perform review of received documentation for raw materials and perform the required task to release for production use. Perform inspections, checks, tests, and sampling of plasma coated samples and/or medical devices.

• Follow LAB sampling procedures and directions for recording and reporting quality data
• Review and revise LAB/SOP procedures as needed
• Review the implementation and efficiency of quality and inspection systems for lab activities
• Conduct testing and inspection of raw materials and products to ensure adequacy of finished product quality as required by the customer
• Assist in the investigation of customer complaints and non-conformance issues
• Have direct contact with suppliers for lab sample testing (request quotes and generate purchase orders)
• Schedule and maintain clean room verification audits
• Maintain weekly records for cleanroom (environmental) requirements and clean line requirements
• Maintain calibration history files and logs and all duties applicable for ensuring tools and equipment receive calibration as required
• Perform verifications on hand held inspection instruments and associated fixtures
• Schedule and supervise calibration services provided by approved contractors
• Perform XRD testing on powdered hydroxyapatite by following written SOPs
• Perform standard methods for tensile (ASTM F1147), shear (ASTMF1160, and metallographic (ASTMF1854) testing
• Participate in material review boards (MRB) as needed relating to received materials that may be found as nonconforming
• Assist in ongoing compliance with quality and industry regulatory requirements
• Often required to perform inspections of purchased parts, subassemblies or finished company products according to well defined criteria using standard physical, mechanical and/ or visual methods. Document material nonconformance as required

Requirements:

Required Education and Experience High School Diploma or equivalent Knowledge of ISO 13485 and FDA CFR requirements Preferred Experience: knowledge of tensile testing, XRD analysis, process monitoring of bioburden, endotoxins, cytotoxicity Quality inspections on received materials/documentation and mechanical laboratory testing experience Strong computer skills including Microsoft Office SAP knowledge and experience a plus SPC Charting (statistical analysis and rationale)

Skills Attention to detail is absolute when reviewing received documentation, in process documentation/procedures, and performing daily activities Strong communication skills - verbal and written Data collection, data management and analysis Problem analysis and problem solving Planning and organizing Teamwork Time Management

Other information:

Lincotek Medical provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.