- Design Controls
- Mechanical Knowledge
- Certified Quality Engineer
- Controlling Experience
This role is responsible for the, implementation, and improvement of overall quality systems. The Associate 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 Associate Quality Engineer may work closely with suppliers or contractors, including auditing, developing inspection/testing plans, performing risk analysis.
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 Software Quality Plans for the product development team.
Support Design Control activities such as Product Requirement Specifications, Software Requirement Specifications, Risk Management Plan, Usability, Design Verification and Design Validation.
Protocol and Test report review and approval.
Coordination of quality components to support on time product launches.
Evaluate product and process changes for qualification and validation requirements and assist in change implementations.
Develop new quality initiatives, participate in quality system development, procedure writing and review, and improve quality and reliability of products
Bachelor's degree in an engineering discipline (e.g. BSIE, BSME, BSEE, or BSBME).
0-2 Years of experience in a regulated environment in Quality Engineering and/or Quality Assurance (QSR, ISO 13485, IEC 60601-1, IEC 62304 and the MDD).
Medical Device Experience.
Design Controls Experience.
Software based product Quality Engineering 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, 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.
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.