Job Summary and Primary Responsibilities
Designs, implements, and maintains quality assurance protocols and methods for developing devices and systems and processing materials into finished products. Guides the compliance of development, manufacturing, and production processes with internal and external safety, quality, and regulatory standard requirements for worldwide distribution. Supports the analysis of reports and production data to help identify trends and recommend updates or changes to product lines, quality standards, and procedures. Upholds the company's quality standards and testing systems to reflect efficiency, reliability and performance. Assists in the creation of documentation including risk management files and provides guidance to engineering on the development and maintenance of design history file documents during new product introductions.
- Provides quality support on design changes to existing products and the entirety of moderately complex projects requiring familiarity with and understanding of the required design control documentation.
- Reviews product and process changes for qualification and validation requirements and assists in change implementations
- Provides technical input on risk management and ensures successful implementation of the risk management program for safety and security product elements, as applicable.
- Implements systems to ensure timely quality inspections for incoming materials, components or finished goods products, and performs inspections as needed.
- Conduct investigations on complaints or audit issues as quality system feedback are provided
- Supports the Non-Conforming Material program and general Design Control activities such as risk assessment, design verification, and validation, as well as sterilization and packaging validation
- Assists with new quality initiatives, participating in quality system development and procedure writing and review to improve the quality and reliability of products
- Performs other duties as assigned
Required Skills / Capabilities
- Proficient in computer technology, including MS Office applications, with good analytical and problem-solving skills
- Experience in the medical device industry with software, including software as a component of electromechanical systems for medical devices
- Experience with cybersecurity requirements and cybersecurity interfaces with quality processes and systems is strongly preferred
- Able to work efficiently in a team environment
- Strong attention to detail and good organizational skills
- Perform duties in compliance with applicable FDA, state, and international regulations as well as standards including, but not limited to, ISO 13485, ISO 14971, IEC 60601, UL 2900 and EU MDR
- Able to leverage root cause analysis, DMAIC, fishbone diagrams, and other quality tools to review and close quality system documents such as non-conformances, reworks, CAPAs, deviations, etc.
- Understands basic statistical concepts and how they support sampling plan justifications, confidence, and reliability measure
- Familiar with design history files and the documentation of user needs, subsequent verification and validation tests, and risk analysis to support the launch of medical devices.
- Familiarity with agile and scrum development processes.
Education and Experience
- Typically requires a Bachelor's degree and a minimum of 2 years of related experience; or an advanced degree without experience; or equivalent work experience
For roles that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable).
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 www.nuvasive.com .