Quality Assurance Specialist
US, US, CA - San Diego
Minimum Level of Education Required: Associates Degree
Percentage of Travel: No travel required
Location: CA - San Diego
In this role, you are a key member of the QA Product Monitoring team. You will support the Quality Assurance and Regulatory Affairs teams through the creation/maintenance of analytical tools and databases to facilitate Post-Market surveillance, regulatory compliance, regulatory submissions and product innovation/improvement activities. Each day will offer new challenges as you tackle a variety of tasks as you help the QA Product Monitoring Team meet our goals and support our customers by performing the following essential duties including:
- Design, create and verify/validate routine and ad-hoc reports regarding various aspects of complaint activities to multiple departments in different locations.
- Build and maintain databases used for monthly and ad-hoc reporting.
- Compile/summarize complaint and/or service information related to Risk Management activities.
- Develop and maintain on-demand tools for use by other team members to assist in their analysis of operations.
- Develop and implement system improvements based on user requests and Quality Improvement projects.
- Responsible to generate/develop trend reports, as well as monthly/quarterly reports on post-market surveillance data.
- 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.
- 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.
- 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.
- Develops and implements solutions to streamline flow of information and returned material related to Post-Market Surveillance activities.
- Manages changes to Product Lifecycle Management functions in current ERP systems such as Material Controls/Material Master, Quality Notifications, Returned Material processes in support of regulatory compliance and business process enhancement.
- Working cross-functionally, identifies and supports the resolution of issues through the coordination of investigations, identification of adverse trends, and management of complaint and product performance processes.
- Provide follow-up to internal and external customers as needed.
- Bachelor’s Degree (B.A/B.S) or equivalent from a college or university.
- 3-5 years related experience and/or training; or equivalent combination of education and experience.
- Strong understanding of regulatory topics, including trends in the medical device industry pertaining to compliance.
- Strong understanding of Medical Device and/or Tissue regulatory requirements.
- Must have strong Excel capabilities, including experience in standard formula building, IF statements, standard calculations, Vlookup, charting/graphing, pivot tables.
- 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.
- Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume.
- Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and/or concrete variables.
- Knowledge of international and domestic regulatory compliance reporting requirements.
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 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.