Quality Lab Tech

Objective

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

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.

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.

This is a full-time position, Monday thru Friday 8:30am to 5:30pm, with additional hours as business needs necessitate.

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).

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.

Employment is contingent upon successfully passing both Background and Drug Pre-Employment Screenings.