Senior Quality Technician, (3rd shift)

US, US, OH - Dayton

Minimum Level of Education Required: High School/Equivalent

Percentage of Travel: No travel required

Location: OH - Dayton

Ref#: 11240

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Job Description

ABOUT NUVASIVE®

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.

 Job Description
 
  • 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.
  • 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.
  • Will support the training and development of Associate Quality Technicians and standard technicians in the advancement of their skill sets and knowledge in Metrology.
  • 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.  

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.

Basic Qualifications
  • High School Diploma required.
  • 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.
  • CMM experience helpful.
  • Optical Comparator and camera vision system experience.
Preferred Qualifications
  • 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.
NuVasive is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. The “EEO is the Law” poster options are available here.

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally invasive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes.The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.
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