Quality Assurance Specialist
US, US, TN - Memphis
Minimum Level of Education Required: Bachelors Degree
Percentage of Travel: Up to 10%
Location: TN - Memphis
Assists and supports the organization in complying with, as well as the ongoing preparation, testing, and monitoring of conformance to, the requirements of government regulations and/or regulatory agencies. This role will work with internal teams as assigned to proved Quality & Regulatory support as needed
- Support NuVasive Training program by assisting in the development, tracking, and implementation of training programs.
- Assist in internal and regulatory audits. Support the organization’s audit program by assisting in administrative activities during the conduct of external audits, including facility preparations and scheduling, record retrieval, and documentation of activities.
- Provide support to the CAPA program through investigation, assistance in the timely completion of correction activities, review and filing of objective evidence for CAPA activities, and the performance of effectiveness checks. Assist shareowners in the reconciliation of CAPA records.
- Identify and implement continuous improvement opportunities
- Participate and support the product complaint system that is compliant with domestic and international regulations and standards as applicable. Conduct/guide 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). Performs complaint investigation, analysis and closure of complaint records to ensure the program conforms to required regulations and standards.
Typically requires a minimum of 3 years of related experience with a Bachelor's degree
- Demonstrated ability to respond to inquiries from customers, and/or regulatory agencies in a professional manner.
- In depth Understanding of FDA 21 CFR Part 801, 820, ISO 13485, and other International regulations as relating to medical devices. Requires strong understanding of UDI and other labeling 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 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.
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