Quality Engineer

at  NuVasive Inc

BUILDING THE FUTURE OF SPINE IN THE HEART OF DAYTON, OHIO

We are looking for people just like you to help us achieve our mission to transform surgery, advance care, and change lives. Our Dayton-area team of spine technology leaders is looking for a Quality Engineer that’s ready to disrupt traditional thinking, help improve lives and keep pushing the industry forward.
As a Quality Engineer, you will review product and process changes for qualification and validation requirements. Manage quality action items for all Management of Change processes, including but not limited to: Design Transfer / New Product Launches, Insourcing Activities, Inspection Processes/Fixtures/Equipment, and New Manufacturing Equipment. Implement methods to inspect, test, and evaluate the repeatability and reproducibility of manufacturing processes, products, and production equipment.

Primary Responsibilities

• Conduct investigations on complaints or audit issues as quality system feedback is provided
• Determine Quality Metrics for all manufacturing procedures
• Prepares reports by collecting, analyzing, and summarizing data
• Lead CAPA activities, root cause analysis, and develop of proactive actions to drive down non-conformances
• 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
• Set and track quality engineering goals
• 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

• Previous experience in a quality role or an engineering role in a manufacturing environment
• In-depth understanding of technical documentation/prints/drawings. Proficiency in GD&T is a plus
• Good Analytical Skills
• Attention to detail
• Experience with testing methodologies and statistical analysis
• Able to work effectively in a team environment

EDUCATION AND EXPERIENCE

• Bachelor’s degree and a minimum of 2 years related experience; an advanced degree without experience; or equivalent work experience

TRAVEL AND/OR PHYSICAL REQUIREMENTS

10% travel
Ability to stand and/or walk for long periods of time in a manufacturing environment.
Ability to lift 25 lbs
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

Primary Responsibilities

• Conduct investigations on complaints or audit issues as quality system feedback is provided
• Determine Quality Metrics for all manufacturing procedures
• Prepares reports by collecting, analyzing, and summarizing data
• Lead CAPA activities, root cause analysis, and develop of proactive actions to drive down non-conformances
• 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
• Set and track quality engineering goals
• 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 assigne