At NuVasive, we disrupt traditional thinking in spine surgery. It’s how we became the leader in spine technology innovation, with a mission to transform surgery, advance care, and change lives. And it’s why we need more people in Dayton with our shared vision to keep pushing the industry forward.

We’re looking for individuals who think what others deem unthinkable. Who engineer the seemingly impossible. Here, no idea is too bold. No challenge is too big. We believe that what’s been done before only serves as the groundwork for what could be. We’re always searching for better so we can build the best.

That’s what it will takes to truly change a patient’s life every minute.

As a Quality Engineering Manager, you will oversee and provide quality engineering support for new QMS, product, and process development projects and ongoing projects. Act as second to site quality leader during audits and when site leader is not available. Conduct facility area inspections in support of the Quality System. Provide support during outside facility audits and inspections. Ensure that validation plans are defined and carried out. Oversee the functions and operations of the Quality Engineering department. Devise long term QMS site strategies. Mentor, lead, and performance review of Quality Engineering staff. 

Other Key responsibilities include;

• Participate in resource planning, recruiting, and budgeting.  Attend project meetings and establish activity timelines to meet department and company Goals and Objectives.
• Keep executive staff informed of any issues that adversely impact the Quality
• Provide leadership, guidance, and support for the quality engineering team.
• Prioritizes supports and facilitates the workload to Senior Quality Engineers, Quality Engineers, Asc. Quality Engineers, and Quality Engineering technicians within their Value Stream or Work Stream.
• Reviews and approves monthly quality objectives slide decks and reports to senior management.
• Reviews Design transfer activities to ensure that all deliverables have been met prior to release.
• Reviews and Authorizes Engineering Change Orders, Manufacturing Change Orders, Source of Supply, Control Plans, PFMEA’s, SOP and Procedure change requests
• Review’s nonconformance investigations and corrective actions.
• Develops team members by training them in Quality Sciences, Problem Solving/Six Sigma (PDCA), cGMP and other technical requirements.
• Reviews and approves Quality Plans, Validation Protocols, Test Reports, Engineering Studies and TMV’s. 
• Perform internal and supplier audits
• Create and/or execute Quality Plans.
• Disposition, perform containment, and evaluate the risk of nonconforming material
• Identify root cause and corrective action by supporting the CAPA process.
• Work with manufacturing engineers to implement risk analysis, manufacturing control plans, and inspection plans for in-process and final inspection.  
• Work with manufacturing engineers to evaluate process risk through supporting PFMEA activities
• Support Quality and Manufacturing Engineering to write and Execute Test Method Validation protocols and reports.
• Create and/or execute Engineering studies, Protocols and Test reports.
• Coordination with the Quality Control department to resolve general concerns.
• Support Inspections and Audits
• Support and evaluate process changes for qualification.
• Create and updates SOP’s, WI, and forms as required.
• Supports process development with design transfer activities.
• Supports FDA and ISO 13485 inspections/audits.
• Creates and updates SOP’s, WI, and forms as required
• Performs inspections as needed, or ensures that inspections are performed by qualified personnel, and that inspection results and documentation support the recommended disposition action.   
• Designs and procures production gaging when appropriate.
• Evaluate and qualify manufacturing processes to ensure technical requirements can be met. (MSA, Cpk, assembly validation, etc)  Provide process development and operations with inspection criteria prior to manufacturing.
• Manage process validations and process improvements
• Planning, execution, and responding to QMS documents and problem resolutions
• Planning, execution and ensuring department goals and objectives are met
• Train, guide, influence and mentor Jr. or new Quality Engineers
• Perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13485, 21 CFR 820, and the European Medical Device Regulation.

Typical Requirements:

• Knowledge of Statistical Analysis required.
• Computer literate (i.e. MS Word, MS Excel, MS PowerPoint).
• Preferred Qualifications:
• Expertise in interpreting and applying GD&T. 
• Proficient and accurate with word processing (Word), spreadsheets (Excel), charting, flow charting, and graphs. Competency in navigating the Internet.
• Experience in electronic QMS and ERP systems
• Strong mathematical skills, including statistics. (Tolerance analysis, significance tests, process capability, sampling plans, GD&T).
• American Society for Quality CQE, CQA and or CQM highly desirable
• Strong understand of ISO 13485, CFR 21 820, and/or MDR.
• Strong manufacturing background.
• Clean room experience.

• Requires a bachelor’s degree or comparable experience in a business, science, technical, or engineering discipline (e.g. BSIE, BSME, BSEE, or BSBME). 
• Minimum 5 years of related experience in the medical device industry.
• Proven track record of leadership and managing teams industry
• Working knowledge of United States and international regulations and standards (i.e. QSR, ISO13485, and MDR) required. 

• Up to 10% travel as required 
• Lift up to 25 lbs
• Walking, standing, manufacturing environment