Quality Engineer Technician
US, US, OH - West Carrollton
Minimum Level of Education Required: High School/Equivalent
Percentage of Travel: Up to 10%
Location: OH - West Carrollton
This role is responsible for the, implementation, and improvement of overall quality systems. The (Quality Engineering Tech) Associate Quality Engineer 1 will support GMP, design transfer activities, manufacturing operations, validate processes, problem solve and perform corrective actions through the use analytical data and quality sciences.
- Disposition, perform containment, and evaluate the risk of nonconforming material
- Work with manufacturing engineers and Quality Engineers to draft manufacturing control plans and inspection plans.
- Support Quality and Manufacturing Engineering to Execute Test Method Validation tasks and Gage R&R’s.
- Collect data and develop capability studies for review.
- Coordination with the Quality Control department to resolve general concerns.
- Support Inspections and Audits
- Draft Manufacturing Change Orders for QE review.
- Initiate PR’s and procure gages and quality tools
- Perform First Article Inspections
- Program advanced metrology equipment
- Assist with gage calibration.
- Assist with final inspection as required.
- Assists with collecting supplier data and initiation of the SCAR process.
- Collects KPI data and presents it for review.
- Five or more years of experience in a regulated Medical Device Manufacturing environment (QSR, ISO 13485, IEC 60601-1, IEC 62304 and the MDD) or a Bachelor's degree in an engineering or science discipline (e.g. BSIE, BSME, BSEE, or BSBME) with 0-1 years of work experience.
- Strong computer skills required, comfortable with Excel, Power Point, Word,
- A strong background of performing inspection and test methods.
- A fundamental understanding of Blueprint reading and GD&T ASME Y14.5 principles such as Rule 1, Virtual condition, Degrees of Freedom, MMC and LMC, True Position and Profile tolerances, and datum shift
- Fundamental understanding of machining, polishing, blasting, anodize, cleaning, and assembly processes.
- Fundamental understanding of Measurement System principles, such as Bias, Linearity, Stability, NIST, Test Accuracy ratio, Attribute Agreement Analyses, Repeatability and Reproducibility.
- A strong understanding of 21 CFR 820.60, 21 CFR 820.65, 21 CFR 820.65, 21 CFR 820.72, 21 21CFR 820.80, 21 CFR 820.86, 21 CFR 820.90,
- ASQ CQE, CQT or CQA certification.
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.
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, 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 more than $1 billion in revenues, NuVasive has approximately 2,600 employees and operates in more than 50 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.