Quality Engineer

Quality         ·          US, US, CA – Aliso Viejo             ·       Full time

Quality Engineer

• US, US, CA – Aliso Viejo
• Minimum Level of Education Required: Bachelors Degree
• Percentage of Travel: No travel required
• Location: Aliso Viejo, CA
• Ref#: 106239

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Job Summary and Primary Responsibilities

Designs, implements, and maintains quality assurance protocols and methods for processing materials into finished products. Guides the compliance of manufacturing and production processes with internal and external safety, quality, and regulatory standard requirements for worldwide distribution. Inspects, tests and evaluates the precision and accuracy of production processes and equipment. Supports the analysis of reports and production data to help identify trends and recommend updates or changes to quality standards and procedures. Upholds the company’s quality standards and testing systems to reflect efficiency, reliability and performance. Assists in the creation of documentation to report issues and errors relating to the production process.

• Reviews product and process changes for qualification and validation requirements, and assists in change implementations
• Implements and monitors systems to ensure timely quality inspections for incoming materials, components or finished goods products, and performs inspections as needed
• Conduct investigations on complaints or audit issues.  
• Supports the Non-Conforming Material program (NCR and CAPA) and general Design Control activities such as risk assessment, design verification and validation, as well as sterilization and packaging valid
• Performs other duties as assigned

Required Skills / Capabilities

• Understanding of drafting requirements per ANSI Y-14.5, including basic understanding of Geometric Dimensioning and Tolerancing
• Perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13485
• Strong attention to detail and good organizational skills
• Able to work efficiently in a team environment
• Proficient in computer technology including MS Office applications, with good analytical and problem-solving skills

Education and Experience

• Bachelor’s degree in an engineering discipline, preferably mechanical engineering
• Typically requires a Bachelor’s degree and a minimum of 2 years of related experience; or an advanced degree without experience; or equivalent work experience

Travel and/or Physical Requirements

Minimal travel required

Salary Range: $75,750 – $126,250

For roles that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable).

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, age, 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’s EEO policy is available here.

About NuVasive

NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, with a mission to transform surgery, advance care, and change lives. The Company’s less-invasive, procedurally integrated surgical solutions are designed to deliver reproducible and clinically proven outcomes. The Company’s comprehensive procedural portfolio includes surgical access instruments, spinal implants, fixation systems, biologics, software for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative neuromonitoring technology and service offerings. With more than $1 billion in net sales, NuVasive has approximately 2,700 employees and operates in more than 50 countries serving surgeons, hospitals, and patients. For more information, please visit www.nuvasive.com.

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