Lincotek Memphis Quality Lab Tech; in AOP

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 (ASTMF
  1160, and metallographic (ASTMF
  1854) 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.