Associate, Quality Manager
US, US, OH - West Carrollton
Minimum Level of Education Required: Bachelors Degree
Percentage of Travel: No travel required
Location: OH - West Carrollton
Summary: Leads a team of Quality Control Inspectors and ensures that all products meet NuVasive’s exceptionally high quality standards while ensuring that the velocity of product flow through the function meets supply chain objectives. Builds a team of shareowners that are best in class at execution of quality plans and masters deploying state of the art inspection techniques. Carefully establishes optimal department capacity, and personnel capability through tight collaboration with cross-functional peers that reside globally. Accurately represents QC processes and team to third part auditors such as FDA, ISO 13485 / Notified Body, etc.
Inspires QC team to meet and exceed applicable business objectives.
Responsible for the day to day management and direction of Quality Control Inspectors across 3 manufacturing shifts.
Selects, trains, and develops inspectors to proficiently execute quality plans and competently operate inspection equipment, such as >CMM (PC DMIS) , Keyence, Oasis, Measure-X Based Vision Systems.
Manages gage calibration system.
Reviews and ensures that quality plans for NuVasive medical devices meet capability targets (gage R&R), and meet cost targets.
Eliminates waste in the department through deployment of lean manufacturing techniques, and optimizes existing inspections through six sigma problem solving tools.
Defines, documents, and establishes quality procedures necessary for the compliant and successful operation of the QC function.
Masters applicable elements of Quality System Regulations and standards such as FDA quality System Regulation 21 CFR 820, 803, 1270 and 1271, ISO 13485, and the European Medical Device Directive.
Partners with engineering team on the qualification of equipment required to perform inspection.
Controls non-conforming materials and executes corrective and preventative action process that impact the QC function.
Identifies and deploys process improvements necessary to deliver year over year budgetary and product innovation targets.
Personally grows through self-development initiatives such as attending cutting edge seminars, reading research publications, and staying abreast of immerging trends.
Responsible for the daily activities and supervision of the Ohio Quality Control team. Will provide leadership and direction as well as embrace the following attributes:
- Foster a culture of teamwork and drive processes that sustain continuous improvement in safety, service, quality, and cost
- Leads team to provide on time service in support of Perfect Order goals
- Develops and implements standard processes to ensure consistent and repeatable results
- Looks for problems in a process, determines all root causes, and mitigates any identified risk.
- Creates and maintains a strong working relationship with key functional groups (Customer Service, Distribution, Supply Chain, Product Development, Quality Engineering)
- · Coaches and develops shareowners to ensure they are properly motivated and trained
- Establishes individual goals and provides comprehensive evaluations/feedback to shareowners on their performance to those goals.
- Maintains confidentiality of information provided by company and shareowners
- Develops and maintains collaborative working relationship with other managers
- Partners with others to drive engagement throughout all levels of the facility
- Operates as a self-starter who doesn’t wait to be told what to do
- Demonstrates a willingness to roll up your sleeves and get your hands dirty
- Has an "Attitude of Gratitude"
- Embraces and promotes the unique NuVa culture.
- Bachelor's degree required (preferred in business or technical / engineering)
- Minimum 5 years’ experience in an automotive, aerospace, or medical device inspection and / or engineering capacity; minimum 1-3 years in a management or supervision capacity.
ASQ CQE or CQA certification preferred.
Certification or training in Lean, Six Sigma, 5S
- ISO13485 auditor certification preferred
- Demonstrated experience with the commonly used quality tools (Histograms, Pareto Diagrams, Flowcharts, etc.) as well as improvement techniques (Plan/Do/Check/Act, DMAIC, Kaizen, etc.)
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, 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, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally invasive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes.The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.