US, US, OH - West Carrollton
Minimum Level of Education Required: Bachelors Degree
Percentage of Travel: Up to 10%
Location: OH - West Carrollton
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. Provide support to the Supplier Quality Engineering team through supplier qualification activities and supplier audits.
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.
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.
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 internal Quality Manual and related procedures.
Schedule, plan and lead supplier audits, including creation of audit reports and management of corrective actions related to audit non- conformances
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.
Schedule, track and complete effectiveness checks as needed for both internal audit CAPAs and supplier corrective actions (SCARs)
Evaluate and qualify Suppliers to ensure technical and quality requirements can be met. Evaluation of suppliers may be as part of due diligence in selection of new suppliers, transfer of manufacturing from one supplier to another or as part of second sourcing.
Participate in management reviews, monthly trend reviews, CAPA Review Boards; Monitor quality data sources including, but not limited to, Incoming QC Non-conforming materials; Supplier Audits; Supply Chain issues (e.g. On-Time Delivery, inventory management); Product Complaints; production NCRs, etc. Communicate quality issues to suppliers as needed and provide assistance to develop corrective actions. Provide technical guidance for identifying and resolving quality issues using quality tools and structured problem-solving methodologies.
Identify opportunities for process improvements and support Quality Engineering with implementation of improvements
Bachelor’s Degree (B.A/B.S) or equivalent from a college or university; plus one to five years related experience and/or training; or equivalent combination of education and experience. Strong understanding of quality and 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).