US, US, CA - San Diego
Minimum Level of Education Required: Bachelors Degree
Percentage of Travel: Up to 25%
Location: CA - San Diego
The Quality Engineer is responsible for the, implementation, and improvement of overall quality systems. The Quality Engineer will participate in Design Control activities and provide guidance to engineering on successful creation and maintenance of design history files during new product introductions. The Quality Engineer may work closely with manufacturing or contractors, including auditing, developing inspection/testing plans, performing risk analysis and developing process validation to ensure the quality of new and modified products and processes.
- This role is to support New Product Introduction teams primarily related to our software based products, but may include interfacing hardware and mechanical components.
- Develop Quality Plans for the product development team.
- Support Design Control activities such as Risk Assessment, quality plans, design verification and design validation.
- Protocol and Test report review and approval.
- Coordination of quality components to support on time product launches.
- Identify and qualify equipment required to perform inspection when applicable.
- Evaluate product and process changes for qualification and validation requirements and assist in change implementations.
- For Mechanical interfaces, establish and implement systems to ensure timely quality inspections for incoming materials, components or finished goods. Work with engineering to develop adequate inspection criteria.
- Develop new quality initiatives, participate in quality system development, procedure writing and review, and improve quality and reliability of products
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and/or Experience: Requires a bachelor degree in an engineering discipline (e.g. BSIE, BSME, BSEE, or BSBME). Minimum three years of experience in a regulated environment in Quality Engineering, Quality Assurance and/or Manufacturing / Engineering required (QSR, ISO 13485, and the MDD).
Medical Device experience
Software based product Quality Engineering experience
Protocol and Test Report review and approval experience
Software/Hardware/Mechanical development experience
ASQ CSQE or CQE 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 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.