Quality Assurance Specialist, Product Monitoring Surveillance

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Location :
Aliso, California

Expiry Date :
Tue, 15 Jun 2021 23:59:59 GMT

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Description :
Job Summary and Primary Responsibilities In this role, you are a key member of the QA Product Monitoring team. You will support the Quality Assurance team 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: – Review, process and trend customer complaints. – Help conduct failure investigation reports. – Compile/summarize complaint and/or service information related to Risk Management activities. – 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. – 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. Required Skills / Capabilities – Bachelors 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 regulatory requirements. – Must have strong Excel capabilities, including experience in standard formula building, 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 define problems, collect data, establish facts, and draw valid conclusions. Education and Experience – 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, 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 .