Quality Assurance Inspector/Clerk (2nd shift)

Introduction

We are looking for someone with experience working within the scope of Quality Assurance to join our team as a QA Inspector/Clerk on Second Shift! Our second shift is a 4/10 schedule working ten hour shifts Monday through Thursday.

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 Turner Medical Inc. dba Intech we give our customers a competitive edge in today's highly specialized design and development of OEM orthopedic and spinal instrumentation. We manufacture world-class instruments to meet our customers' most demanding requirements.

About the Quality Assurance Inspector/Clerk Role

Working as a Quality Assurance at Intech will give you the opportunity to gain experience in the quality process of creating complex spinal and orthopedic instruments that improve the lives of patients around the world! Quality Assurance is a well-rounded position that has touchpoints with all aspects of the Quality System, including, but not limited to document control, shipping documentation preparation, parts inspection, general administrative duties maintaining quality documents, record retention, change process, maintaining gage list, and collecting quality data.

Essential Duties and Responsibilities:

• Maintains and prepares inspection and shipping documentation.
• Performs checks to ensure all documents used for quality inspection are complete and accurate.
• Performs general administration duties providing quality documents to customers.
• Responsible for organizing and filing documents used for product (job folders).
• Responsible for ensuring the customer receives all necessary shipping documentation required, such as packing list, Certificate of Conformance, inspection reports, material certifications, and blueprints.
• Communicates any concerns with shipping documentation with the customer, as well as all outgoing shipments to customers.
• Maintains all device history records (DHR).
• Responsible for maintaining overall gage calibration process.
• Maintains gage list, report internally when tools are due for collection, and provide gages to the shop floor and inspection laboratory.
• Works with third-party calibration technician/company to manage gage calibration services for overall process, statuses, quotes and tracking of all gages.
• Collects, tracks, and reports all calibration in software, as well as designates new due dates.
• Escalates out of tolerance gages for evaluation.
• Collects material review board (MRB) data and assigns appropriate locations.
• Ability to take direction from supervisor or manager.
• Read, comprehend, and perform duties as outlined in the Standard Operating Procedures (SOP).
• Always maintain acceptable housekeeping standards to ensure a safe and productive work environment for all employees.
• Continually suggest and support implementation of ideas to improve safety, quality, cost, and on-time delivery; work to help make Intech a better company and better place to work.
• Demonstrate regular and consistent attendance and punctuality. Work overtime as required.
• Perform and practice lean process and all other duties as assigned.
• 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 for external customer returns through an RMA procedure.
• Maintain inspection equipment and verify calibration.

Job Qualifications

• High School Diploma, GED, Trade School, or equivalent work experience.
• 2 years' experience in quality inspection in a manufacturing environment working with quality, engineering, and operations
• Understanding of Geometric Dimensioning and Tolerancing(GD&T)and other advanced inspection concepts.
• Must be able to use a wide range of measurement devices such as optical comparators, dial indicators, micrometers, calipers, threaded and straight plug gages, pitch micrometers, CMM, etc.
• Strong multi-tasking abilities and the ability to work efficiently in a fast-paced and deadline-driven environment.
• Must be able to read and interpret mechanical drawings, specifications and inspection instructions and determine product conformance based on such documents.
• Strong computer software aptitude to include ERP, QMS, and customer software.
• Microsoft Office Suite skills, including Excel, are a must.
• Critical thinking and advanced decision-making skills, as well as mechanical aptitude.
• Ability to conceptualize geometry and assemblies.
• Ability to read, comprehend, follow, and document work instructions, blueprints, routers, and standard operating procedures.
• Ability to collaborate and assist team members, provide input to the area lead, and attend/participate effectively in meetings.
• Ability to work as a Team Member and interact effectively, professionally, and constructively.
• Experience in an ISO/FDA manufacturing facility preferred.