Demo

Quality Control Inspector 1st Shift M-F

Lenkbar LLC
Fort Myers, FL Full Time
POSTED ON 3/9/2025
AVAILABLE BEFORE 6/9/2025

About the Company

Intech is a global market leader and game-changer in the manufacturing of orthopedic medical devices. It all starts with innovation, and nobody knows this better than Intech. With manufacturing facilities around the world and unique initiatives and savoir-faire, Intech is at the forefront of technological innovation in the field of orthopedic device manufacturing as well as asset management, ensuring that optimal patient care is delivered day in, day out. This is who we are. We tech care.

Here at Lenkbar we give our customers the competitive edge in today's highly specialized design and development of cutting tools. We assist with the design and production of a variety of drills, burrs and taps for the orthopedic industry and world class flexible shafts to meet our customers' most demanding requirements. From Swiss turning to precision grinding, we leverage advanced machining techniques and best-in-class equipment that are automated and optimized for performance to support our customers' next critical product launch.

Position Summary :

Responsible for maintaining quality assurance processes, performing inspections and quality assurance testing for analysis of materials, in process, and finished products, recording and analyzing data, and completing required documentation to ensure compliance with all specifications.

Essential Duties and Responsibilities :

  • Read specifications and part prints to interpret requirements including dimensional, physical, functional, and visual requirements.
  • Inspect product for various quality issues using approved methods and procedures.
  • Perform part inspection and measure dimensions of incoming, in process, and finished workpieces to ensure conformance to print specifications, using various precision measuring instruments, optical comparator, CMM or vision machines, along with templates and fixtures.
  • Conduct in process welding, assembly, function and laser mark inspections.
  • Conduct and document first piece inspections as required.
  • Document and communicate testing and inspection results to ensure quality control standards are satisfied.
  • Place non-conforming production on "hold" status and complete NCR paperwork.
  • Collect quality data and enter data into spreadsheets and databases.
  • Verify and support dispositions of nonconforming product whether internal or customer returns through an RMA procedure.
  • Maintain inspection equipment and verify calibration.
  • Communicate with manufacturing, engineering and production personnel from all departments to exchange pertinent information and problem solve issues.
  • Assist with corrective and preventative actions are required.
  • Meet and maintain established efficiency and effectiveness standards established for the quality function.
  • Ensure proper and complete documentation off all inspection paperwork along with all data in ERP system.
  • Complete all documentation per ISO 13485 and FDA requirements.
  • All other duties as assigned.

Knowledge, Skills & Competencies :

  • Minimum of 3 years of quality control experience in medical device company.
  • Experience is ISO / FDA environment .
  • Ability to read and interpret blueprints.
  • Proficient in the use of machine shop precision measuring equipment including micrometer & caliper, height stands, thread gages, dial indicators, gage pins, radius gages, optical comparator and vision machines.
  • Knowledge and understanding of GD&T.
  • Knowledge of the company quality system, as well as contractual quality requirements that vary by customer.
  • Proficient in the use of a computer in a Windows environment, and proficient in Microsoft Excel.
  • Proficient in math, including the ability to add, subtract, multiply and divide.
  • Excellent manual dexterity, hand / eye coordination.
  • Ability to be highly accurate with a high attention to detail.
  • Ability to troubleshoot and problem solve quality and other issues.
  • Ability to read and comprehend work instructions.
  • Ability to repeat the same physical and mental activities over and over.
  • Ability to maintain a sense of urgency, handle stressful situations, multitask and ability to prioritize work.
  • Ability to work in a team environment as well as autonomously.
  • Ability to communicate and interact effectively, professionally and constructively.
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