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NuVasive, Inc. Sterile Packaging Quality Engineer in San Diego, California

Sterile Packaging Quality Engineer

US, US, CA - San Diego

Minimum Level of Education Required:Bachelors Degree

Percentage of Travel:No travel required

Location:CA - San Diego

Ref#:101187

Job Description

NuVasive is looking for a Sterile Packaging Quality Engineer that is passionate about design, development, launch, and maintenance of packaging solutions for their spinal procedural product base. The candidate we’re looking for must be highly collaborative, very organized, accustomed to a fast-paced environment, and a very creative & intelligent problem-solver and someone that can be relied upon to serve the needs of their team and our customers on a daily basis.

Key Responsibilities:

  • Develop Quality Plans for the Sterile Packaging Project.

  • Lead the development of adequate inspection criteria. Identify the need for custom gaging for NuVasive and suppliers.

  • Support transfer of design to contract manufacturer, including the establishment of inspection plans both at NuVasive and at the supplier.

  • Evaluate product changes for qualification and validation requirements and assist in change implementations.

  • Support Design Control activities such as design verification and validation and sterilization/packaging validation.

  • Support the development and implementation of sterile packaging operations.

  • Qualify and manage subcontract supply base, including on-site audits, quality agreements, corrective actions, and validations.

  • Develop new quality initiatives, participate in quality system development, procedure writing, and review, and improve the quality and reliability of products

  • Support Non-Conforming Material Program.

  • Conduct investigations, initiate or process actions from quality system feedback information (records review, acceptance activities, non-conforming materials reports, corrective action reports, complaints, and audit reports) as needed related to sterile packaging.

Basic Qualifications

  • Bachelor's degree in an engineering discipline (e.g. BSIE, BSME, BSEE, BSBME, or BSCSE)

  • Three years minimum experience in a regulated environment in Quality Engineering, Assurance and or Manufacturing / Engineering (design) environment required (QSR, ISO 13485, and the MDD). American Society for Quality Certified Engineer (CQE) desirable

Preferred Qualifications

  • Medical Device Development, Quality Engineering, Validation experience; Sterile Packaging experience; Mechanical Print Interpretation and GD&T

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 at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm . NuVasive's EEO policy is available here at https://www.nuvasive.com/wp-content/uploads/2019/06/COP-NUV-HR0004-7.pdf .

About NuVasive

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 at http://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, 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 at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm . NuVasive's EEO policy is available here at https://www.nuvasive.com/wp-content/uploads/2019/06/COP-NUV-HR0004-7.pdf .

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.

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