Manager, Quality Engineering

Quality            ·           US, US, OH – West Carrollton             ·       Full time

Manager, Quality Engineering

• US, US, OH – West Carrollton
• Minimum Level of Education Required: Bachelors Degree
• Percentage of Travel: Up to 10%
• Location: Dayton, OH
• Ref#: 106249

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Job Summary and Primary Responsibilities

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 take to truly change a patient’s life every minute.

Join our team.

Key Responsibilities:

• Oversee and provide quality engineering support for new QMS, product, and process development projects and ongoing projects.
• Mentor direct reports and other employees coaching a culture of rapid problem-solving and learning.  (Kata, CAPA, PDCA, Six Sigma)
• Act as second to site quality leader during audits and when the 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 process validation and test method 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 reviews of Quality Engineering staff. 
• 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.
• Review nonconformance investigations and coaches their team.
• Reviews approves and coaches their team on good technical writing Quality Plans, Validation Protocols/Reports, Engineering Studies, SOP’s and WI’s. 
• Work with manufacturing engineers to implement risk analysis (pFMEA), manufacturing control plans, and inspection plans for in-process and final inspection.  
• Coordination with the Quality Control department to resolve general concerns.
• Performs inspections as needed, or ensures that inspections are performed by qualified personnel and that inspection results and documentation support the recommended disposition action.   
• Manage process validations and process improvements.
• Planning, executing, and ensuring department goals and objectives are met.

Required Skills / Capabilities

• Demonstrated experience and performance with of Problem-Solving Techniques (PDCA, Six Sigma)
• Experience with ERP systems
• Proven track record of leadership and managing teams.
• Demonstrated experience and performance with statistical techniques (Capability, SPC, T-Test, DOE, Chi Square, ANOVA, Regression, etc.)
• Strong understanding of GD&T 
• Demonstrated experience and performance of Measurement Systems (Calibration, R&R, Measurement Uncertainty)
• Demonstrated experience and performance in setting goals, analyzing trends, and creating countermeasures.

Preferred:  

• Experience with Manufacturing Execution Systems (MES)
• Experience in clean room environments.
• ASQ, CQE, CRE, CQA, CSSG(B)B, CMQ/OE, CSQP

Education and 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.
• Working knowledge of the United States and international regulations and standards (i.e. MDR, ISO13485, and MDR) is required. 

Travel and/or Physical Requirements

• Travel up to 10%  
• Visual acuity 20/20 with or without corrective lenses 

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.

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