Quality Lab Analyst

Lincotek Group; Memphis (TN); On-site; USD 42,000 - 70,000; Full time

Job summary

Lincotek Group in Memphis, TN seeks an experienced QA/Testing Technician to analyze, test, and document results for product releases. You will ensure reliability, usability, and performance per customer standards, review documentation for raw materials, and release materials for production.

Responsibilities include conducting inspections, tests, sampling, and MRB participation, plus maintaining calibration histories and working with suppliers.

Qualifications

• High school diploma required; knowledge of ISO 13485 and FDA CFR preferred.
• Experience with tensile testing, XRD, and process monitoring of bioburden/endotoxins/cytotoxicity is a plus.
• Strong computer skills including Microsoft Office; SAP knowledge a plus; SPC charting helpful.

Responsibilities

• Follow lab sampling procedures and record quality data.
• Review and revise LAB/SOP procedures as needed.
• Review quality and inspection systems for lab activities.
• Test and inspect raw materials and products to assure finished quality.
• Assist in investigations of customer complaints and non-conformances.
• Interact with suppliers for lab sample testing and purchasing.
• Schedule and maintain clean room verification audits.
• Maintain weekly records for environmental and clean line requirements.
• Maintain calibration history and ensure equipment is calibrated.
• Verify handheld inspection instruments and fixtures.
• Schedule calibration services with approved contractors.
• Perform XRD testing on powdered hydroxyapatite per SOPs.
• Perform tensile, shear, and metallographic testing per standards.
• Participate in MRB for nonconforming materials.
• Assist in regulatory compliance for quality standards.
• Inspect purchased parts and document nonconformance.

Skills

Attention to detail

Data analysis

Communication

Problem solving

Planning

Teamwork

Time management

Education

High School Diploma

ISO 13485 / FDA CFR knowledge

Tools

SAP

SPC Charting

XRD analysis

Job description

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.

Essential Functions

1. 1. Follow LAB sampling procedures and directions for recording and reporting quality data
2. 2. Review and revise LAB/SOP procedures as needed
3. 3. Review the implementation and efficiency of quality and inspection systems for lab activities
4. 4. Conduct testing and inspection of raw materials and products to ensure adequacy of finished product quality as required by the customer
5. 5. Assist in the investigation of customer complaints and non-conformance issues
6. 6. Have direct contact with suppliers for lab sample testing (request quotes and generate purchase orders)
7. 7. Schedule and maintain clean room verification audits
8. 8. Maintain weekly records for cleanroom (environmental) requirements and clean line requirements
9. 9. Maintain calibration history files and logs and all duties applicable for ensuring tools and equipment receive calibration as required
10. 10. Perform verifications on hand held inspection instruments and associated fixtures
11. 11. Schedule and supervise calibration services provided by approved contractors
12. 12. Perform XRD testing on powdered hydroxyapatite by following written SOPs
13. 13. Perform standard methods for tensile (ASTM F1147), shear (ASTMF1160, and metallographic (ASTMF1854) testing
14. 14. Participate in material review boards (MRB) as needed relating to received materials that may be found as nonconforming
15. 15. Assist in ongoing compliance with quality and industry regulatory requirements
16. 16. 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

Work Environment

This job operates in both an office environment and a manufacturing environment. The role routinely uses standard office equipment, such as computers, phones, photocopiers, filing cabinets and fax machines. The individual will be required to adhere to safety policies and procedures on the manufacturing floor.

Physical Demands

While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand, walk, use hands to finger, handle or feel and reach with hands and arms.

The employee is occasionally required to sit, climb or balance and stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 10lbs and occasionally lift and or move up to 50lbs. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

Required Education and Experience

High School Diploma. 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