NuVasive, Inc. Quality Technician in West Carrollton, Ohio

Quality Technician

US, US, OH - West Carrollton

Minimum Level of Education Required:High School/Equivalent

Percentage of Travel:No travel required

Location:OH - West Carrollton

Ref#:17345

Job Description

The Quality Technician is responsible for any activities involving quality assurance and compliance with applicable regulatory requirements; conducts audits and reviews/analyzes data and documentation. Primary support functions are inspection (e.g. first article), data collection, maintenance of quality records, analyzing and solving problems, administration of quality systems such as Non-Conforming Material Reports, Repair Action Plans, and any other quality function deemed appropriate by Quality Leadership.

ESSENTIAL JOB FUNCTIONS

The 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.

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.

Quality Technician 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: Technician will be responsible for performing incoming material and component inspection as directed by inspection plans. Technician shall be proficient in use of hand inspection tools such as calipers, micrometers, height gauges, plug and pin gauges. Additionally, technician shall use Coordinate Measurement Machines (CMMs), Vision Systems (MeasureX / MeasureFIT), and Keyence.

Calibration: Technicians 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 gauge calibration database. Technicians will ensure gauges and gauge kits are prepared and available for production and process development.

Process Development Support : 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 develop inspection procedures including manufacturing plans and work instructions.

Production Support: Technician shall support production by providing guidance to operators on inspection methods, metrology, gauging, 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.

  • 2-5 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. Understanding of GD&T is required.

Preferred Qualifications

American Society for Quality (ASQ) certifications, Certified Quality Improvement Associate (CQIA), Certified Quality Inspector (CQI), or Certified Quality Technician (CQT) is preferred.

Associates degree in a technical discipline is 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 at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm .

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.

©2015 NuVasive®, Inc. Privacy at http://www.nuvasive.com/privacy-policy/ Terms and Conditions at http://www.nuvasive.com/terms-conditions/

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 at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm .

Nuvasive is committed to working with and providing reasonable accommodation to individuals with disabilities. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, including the use of this website, please contact us at careers@nuvasive.com.