Sunday , April 21 2024

NuVasive Jobs – Quality Assurance Specialist

Website NuVasive

Job Description:

In this role, you are a key member of the QA Product Monitoring team. You will support the Quality Assurance team through the creation/maintenance of analytical tools and databases to facilitate Post-Market surveillance, regulatory compliance, regulatory submissions and product innovation/improvement activities.

Job Responsibilities:

  • Provide data analyses in support of internal and external customers as needed, including data related to customer correspondence, surgeon meetings, site visits and regulatory agency correspondence.
  • Compile/summarize complaint and/or service information related to Risk Management activities.
  • Develop standardized reporting mechanisms for departmental, corporate and product Quality Improvement metrics via current ERP/Business Intelligence platforms to support Quality Assurance and Regulatory Affairs users, including query generation, charts and analysis of Post-Market Surveillance data.
  • Help conduct failure investigation reports.
  • Review, process and trend customer complaints.
  • Support ensuring that quality system activities are in place and are conducted in accordance with applicable regulations and standards including, but not limited to, U.S.
  • FDA Quality System Regulations, ISO (International Organization for Standardization) Standards.

Job Requirements:

  • Must have strong Excel capabilities, including experience in standard formula building, Vlookup, charting/graphing, pivot tables.
  • Strong understanding of Medical Device regulatory requirements.
  • Strong understanding of regulatory topics, including trends in the medical device industry pertaining to compliance.
  • 3-5 years related experience and/or training; or equivalent combination of education and experience.
  • Bachelor’s Degree (B.A/B.S) or equivalent from a college or university.
  • Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to speak effectively before groups of customers or employees of the organization.

Job Details:

Company: NuVasive

Vacancy Type: Full Time

Job Location: Bakersfield, CA, US

Application Deadline: N/A

Apply Here