Lincotek Memphis Quality Lab Tech (in AOP)
Lincotek Group · Tennessee, United States · 1 mo ago
On-siteQuality AssuranceFull-time
Company Overview
Lincotek, headquartered in Rubbiano, Parma, Italy, is a global contract manufacturer serving markets including industrial gas turbines, aerospace, and medical device applications. The group also manufactures industrial coating equipment and is a leading producer in the additive manufacturing field. Lincotek employs more than 1,800 people across 18 production facilities in Europe, North America, and Asia.
Responsibilities
- Analyze, perform testing, and generate documentation with results for product release.
- Ensure results meet established quality standards—including reliability, usability, and performance—as required by customers and regulations.
- Review received documentation for raw materials and complete tasks needed to release them for production use.
- Inspect, check, test, and sample plasma‑coated samples and/or medical devices.
- Follow laboratory sampling procedures and record/report quality data.
- Review and revise laboratory SOPs as needed.
- Assess the implementation and efficiency of quality and inspection systems for lab activities.
- Conduct testing and inspection of raw materials and products to ensure finished‑product quality meets customer requirements.
- Assist in investigating customer complaints and non‑conformance issues.
- Maintain direct contact with suppliers for lab sample testing, including requesting quotes and generating purchase orders.
- Schedule and maintain clean‑room verification audits.
- Maintain weekly records for clean‑room (environmental) and clean‑line requirements.
- Maintain calibration history files and logs, ensuring tools and equipment are calibrated as required.
- Verify handheld inspection instruments and associated fixtures.
- Schedule and supervise calibration services provided by approved contractors.
- Perform X‑ray diffraction (XRD) testing on powdered hydroxyapatite following written SOPs.
- Execute standard tensile (ASTM F1147), shear (ASTM F1160), and metallographic (ASTM F1854) testing methods.
- Participate in material review boards (MRB) as needed for non‑conforming received materials.
- Assist in ongoing compliance with quality and industry regulatory requirements.
- Inspect purchased parts, subassemblies, or finished products using defined physical, mechanical, or visual criteria.
- Document material non‑conformance as required.
Requirements
- High School Diploma or equivalent.
- Knowledge of ISO 13485 and FDA CFR requirements.
- Preferred: knowledge of tensile testing, XRD analysis, and process monitoring of bioburden, endotoxins, and cytotoxicity.
- Preferred: experience with quality inspections of received materials/documentation and mechanical laboratory testing.
- Preferred: strong computer skills, including Microsoft Office; SAP knowledge and experience are a plus.
- Preferred: SPC charting (statistical analysis and rationale).
Skills
- Exceptional attention to detail when reviewing documentation, procedures, and daily activities.
- Strong verbal and written communication skills.
- Data collection, management, and analysis.
- Problem analysis and problem‑solving.
- Planning and organizing.
- Teamwork.
- Time management.