US, US, OH - Dayton
Minimum Level of Education Required: High School/Equivalent
Percentage of Travel: No travel required
Location: OH - Dayton
NuVasive is an innovative medical device company focused on developing minimally disruptive surgical products and procedurally integrated solutions for the spine. The Company is the 3rd largest player in the $8.2 billion global spine market. With a focus on Speed of Innovation®, Absolute Responsiveness®, and Superior Clinical Outcomes, we are revolutionizing how spine procedures are performed on patients around the world.
If you work hard to deliver outstanding results and are passionate about making an impact in people’s lives, join our team of “A Players” and help change spine surgery. We are looking for a highly talented and innovative Quality Technician to join the Manufacturing team at our location in Dayton, Ohio.
ESSENTIAL JOB FUNCTIONS
The Senior Quality Technician is responsible for Quality Inspection, Quality Engineering Support, and Calibration / Metrology services in support of production, including development, implementation, improvement and maintenance of SPC functions for production and quality systems.
The Senior Quality Technician will support the development of manufacturing processes, inspection and testing plans, risk analysis and process validation to ensure the quality of new and modified products and processes in a CNC Manufacturing Environment.
The Senior Quality Technician will support the training and development of Associate Quality Technicians and standard technicians in the advancement of their skill sets and knowledge in Metrology.
Senior Quality Technicians will adhere to industry best practices in addition to their duties being performed in compliance with applicable regulations and standards including FDA Quality System Regulation 21: CFR 820, ISO 13485, and the European Medical Devise Directive.
DUTIES AND RESPONSIBILITIES
Inspection: The Senior Quality Technician will be responsible for performing incoming material and component inspection as directed by inspection plans. The Senior Quality Technician shall be proficient in use of hand inspection tools such as calipers, micrometers, height gages, plug and pin gages. Additionally, technician shall use Coordinate Measurement Machines (CMMs), Vision Systems (MeasureX / MeasureFIT), and Keyence.
Calibration: The Senior Quality Technician shall perform calibration services. This will include the need to inspect, test, maintain and repair a variety of inspection equipment to ensure measurement accuracy. Any measurement errors must be quickly identified and corrected. Technicians must compile, measure and record data from each instrument for other technicians, managers, and engineers to review.
Maintains the gage calibration database. The Senior Quality Technician will ensure gages and gage kits are prepared and available for production and process development.
Process Development Support: The Senior Quality Technician shall support Manufacturing Engineers, Quality Engineers, Programmers and Machinists during the development, assembly, troubleshooting, prove out, capability studies, first article inspection, process validation or test method validation. This shall include planning inspection methods, inspecting parts, training machinists and operators, and troubleshooting inspection methods on the CMM, vision systems, Keyence, Oasis, or other methods. With minimal supervision, design effective and efficient inspection techniques for First Articles, Custom Gages, Investigations and Test Parts. Will support development of inspection procedures including manufacturing plans and work instructions.
Production Support: The Senior Quality Technician shall support production by providing guidance to operators on inspection methods, metrology, gaging, etc. Technicians shall facilitate Statistical Process Control for the facility including escalation of abnormal events such as out of tolerance or special causes. Participates in NCR process and MRB process.
Support other work of the Q.E. Department, as required.
Perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13485, MDD 93/42 CEE.
5 or more years of experience in a regulated environment required (e.g., QSR, ISO 13485, and the MDD.
Candidate must be proficient in ASME Y14.5M and blueprint reading. Proficient in understanding of GD&T is required.
Associates degree in a technical discipline is preferred.
American Society of Quality (ASQ) certifications, Certified Quality Improvement Associate (CQIA), Certified Quality Inspector (CQI), or Certified Quality Technician(CQT) is strongly preferred.
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