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Sr. Internal Quality Auditor

  • Anywhere

Company :
NuVasive

Location :
San Diego, California

Expiry Date :
Mon, 14 Jun 2021 23:59:59 GMT

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Description :
Job Summary and Primary Responsibilities This role is responsible for the review, development, and performance of internal audit procedures and preparing internal audit reports reflecting the results of the work performed. This includes periodically testing and assessing quality control systems to ensure that a company’s practices conform to both internal and external standards. Essential Responsibilities: – Support the NuVasive QMS internal audit program by 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 – 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 – 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 corrections and corrective action (CAPA) activities – Develop action plans intended to support the global internal audit strategy Required Skills / Capabilities – Prior Quality Auditing (or experience in one quality subsystem) experience in a medical device/other FDA regulated GMP environment – Report writing skills – Proficient and accurate with word processing (Word), spreadsheets (Excel), presentation programs (Power Point), charting, flow charting, and graphs – Experienced in the use of ERP systems (e.g. SAP, Oracle) as well as electronic quality management systems (eQMS) Education and Experience – Bachelor’s degree in business, engineering, or scientific discipline (e.g. chemistry, life sciences) – ASQ certification (CQA or CBA would be ideal) or Lead Auditor (ISO 13485) certification – Formal technical writing – Formal process analysis/quality tool skills – Experience in Tissue Bank requirements or Spine/machining industry – Experience auditing to MDSAP – Multi-site operation quality experience – Understanding of various vertical standards like sterilization, clean room, risk management #LI-CL1 Travel and/or Physical Requirements – Ability to travel up to 30% 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, age, 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’s EEO policy is available here. About NuVasive NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, with a mission to transform surgery, advance care, and change lives. The Company’s less-invasive, procedurally integrated surgical solutions are designed to deliver reproducible and clinically proven outcomes. The Company’s comprehensive procedural portfolio includes surgical access instruments, spinal implants, fixation systems, biologics, software for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative neuromonitoring technology and service offerings. With more than $1 billion in net sales, NuVasive has approximately 2,700 employees and operates in more than 50 countries serving surgeons, hospitals, and patients. For more information, please visit .