US, US, CA - San Diego
Minimum Level of Education Required: Bachelors Degree
Percentage of Travel: Up to 50%
Location: CA - San Diego
Summary: Provide leadership and support to the compliance function through the identification, execution and administration of elements of the NuVasive Quality Management System (QMS) internal audit program.
Essential duties and responsibilities: May include one or more of the following. An area of specialty within these tasks may be assigned. Other duties may be assigned.
1. Support the NuVasive QMS internal audit program by identifying audit needs and performing audits of internal US and international NuVasive affiliate sites. These audits will vary in frequency, scope, and depth depending on business and compliance requirements, and will be customized to the capability, performance, and risk levels of the auditee organizations.
2. Schedule and conduct internal audits in the capacity of lead auditor, in accordance with internal procedures. Present the internal audit program to external auditors. Audits will typically be performed to evaluate conformity with ISO 13485, 21CFR820, 21CFR1271, AATB, MDD, CMDCAS, and other relevant external standards and regulations, as well as interal Quality Manual and related procedures.
3. Administration of the internal audit program will include the development of internal audit schedules, classifying the audit subjects based on risk and previous audit performance levels.
4. Document and track assigned audit observations and recommendations to closure through the corrective action (CAPA) system, and provide leadership and guidance to members of the organization in the resolution of quality system deficiencies in accordance with regulatory requirements and standards.
5. Schedule, track and complete effectiveness checks as needed for both corrections and corrective action (CAPA) activities.
Bachelor’s Degree (B.A/B.S) or equivalent from a college or university; plus three to five 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.
Proficient and accurate with word processing (Word), spreadsheets (Excel), presentation programs (Power Point), charting, flow charting, and graphs. Competency in navigating the Internet. Experienced in the use of ERP systems (e.g. SAP, Oracle) as well as electronic quality management systems (eQMS).
ASQ certification (CQA or CBA would be ideal).
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