NuVasive, Inc. Validation Engineer in Memphis, Tennessee

Validation Engineer

US, US, TN - Memphis

Minimum Level of Education Required:Bachelors Degree

Percentage of Travel:Up to 50%

Location:TN - Memphis

Ref#:16860

Job Description

Work with overseas subsidiaries and internal Quality team on:

  • Comprehensive understanding and experience of QSR, ISO 13485:2016, MDSAP, and any other applicable regulatory standards.

  • Develop and execute project plan for global validation and asset management activities.

  • Develop validation master plans, validation protocols, summary reports, deviations, process flow diagrams, test cases, and standard operating procedures/work instructions as applicable.

  • Author and execute, IQ, OPQ.

  • Prepare validation or performance qualification protocols for new or modified processes, systems, and other types of production.

  • Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.

  • Lead periodic review of equipment and critical utilities.

  • Lead cleaning validation and annual monitoring projects.

  • Conduct audits of validation or performance qualification processes to ensure compliance with internal and regulatory requirements.

  • Manage projects in a matrix organization as a team leader.

  • Author and execute validation protocols and summary reports for equipment qualifications, process and packaging validation, and cleaning validation processes to ensure regulatory agency compliance.

  • Support validation life cycle activities by commissioning, continuous process monitoring, change controls, SOP generation, and revalidation activities.

  • Support and lead special projects and serve as a quality liaison to operations.

  • Support regulatory and internal audits, for both domestic and international markets.

  • Travel 25% international and domestic.

Perform duties in compliance with applicable FDA, state, and global regulations as well as standards including, but not limited to, ISO 13485.

Work independently with minimal supervision to attain project goals and meet timelines.

Prior experience in development and implementation of validation plans. Demonstrated project management in Medical Device industry.

Basic Qualifications

Requires a minimum of 8 years of related experience with a Bachelor’s degree; or 6 years and a Master’s degree; or a PhD with 3 years experience; or equivalent experience.

Manufacturing experience working in medical/aeronautical industry is helpful.

Preferred Qualifications

  • PMP certification

  • Six Sigma Black Belt

  • Proficient in Minitab

  • ASQ certifications

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 at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm .

About NuVasive

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.

©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, 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 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.