Quality Engineer

At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and outcomes of surgery so patients can resume their lives as quickly as possible.

NML Medical in West Carrollton, Ohio, a subsidiary of Globus Medical Inc., manufactures a wide range of implants for spinal and orthopedic applications and the instrumentation cases that house them. Our passion for design and manufacturing, combined with Globus' world-class engineering, transforms clinical insights into tangible musculoskeletal solutions. Our mission is to deliver products and technologies that change the lives of patients around the world.

The Quality Engineer position is with NML Medical, LLC (f/k/a NuVasive Manufacturing, LLC), part of the Globus group of companies.

Essential Functions:

Design, implement and maintain quality assurance protocols and methods for processing materials into finished products;

Ensure compliance of manufacturing and production processes with internal and external safety, quality, and regulatory standard requirements for worldwide distribution;

Inspect, test and evaluate the precision and accuracy of production processes and equipment;

Support analysis of reports and production data to help identify trends and use quality tools to rectify negative trends;

Ensure adherence to company's quality standards to reflect efficiency, reliability and performance;

Assist in the creation of documentation to report issues and errors relating to the production process;

Review product and process changes for qualification and validation requirements and assist in change implementations;

Implement systems to ensure timely quality inspections for incoming materials, components or finished goods products, and perform inspections as needed;

Conduct investigations on complaints or audit issues as quality system feedback is provided;

Provide technical expertise to the Non- Conforming Material program and general Design Control activities such as risk assessment, design verification and validation;

Assist with new quality initiatives, participating in quality system development and procedure writing and review to improve the quality and reliability of products;

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;

Determine Quality Metrics for all manufacturing procedures; and

Lead CAPA activities, root cause analysis, and development of proactive actions to drive down non-conformances.

Qualifications:

Bachelor's degree or foreign equivalent in Mechanical Engineering, Industrial Engineering, or a closely related engineering field;

3 years of experience as a Quality Engineer or closely related role;

Experience working in the medical devices industry (at least 2 years);

Experience working with 21 CFR 820 and ISO 13485;

Experience supporting new product introduction & design transfer activities;

Experience performing statistical analysis such as Normality Stability, Capability, Design of Experiment, T-tests, ANOVA, and Regression;

Experience leading and supporting validation activities including installation qualifications, operational qualifications, and process qualifications;

Experience drafting product validation protocols and supporting the execution of validation protocols;

Experience conducting root cause analysis using methods such as 8D, 5Ws, and Fishbone Diagram;

Experience with Thermal Plasma Spray Coating processes (at least 2 years);

Experience reviewing Quality Hold products & provide disposition; and

Experience with Special process validations (i.e. additive manufacturing) (at least 2 years).

Our Values:

Our Life Moves Us philosophy is built on four values: Passionate About Innovation, Customer Focused, Teamwork, and Driven.

Passionate about Innovation: Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate in our role in improving the lives of patients by continuously developing better solutions.

Customer Focused: We listen to our customers' needs and respond with a sense of urgency.

Teamwork: Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger.

Driven: We pursue our mission with energy and passion. We are nimble, results-oriented and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients.

Equal Employment Opportunity:

Globus Medical is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin or citizenship. We are committed to a diverse workforce. We value all employees' talents and support an environment that is inclusive and respectful.

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.