Sr. Quality Engineer

Branch Medical Group, a subsidiary of Globus Medical Inc., manufactures a wide range of implants for spinal and orthopedic applications as well as design the instrumentation cases that house them. Our passion, combined with Globus’ world-class engineering, transforms clinical insights into tangible musculoskeletal solutions. We are constantly in pursuit of better patient care and understand that speed is critical because life cannot wait.

Position Summary:

The Quality Engineer is responsible for ensuring compliance in product and process development, validations and process optimization, line support, acceptance sampling, and continuous improvement for Class III medical devices. This effort includes, but is not limited to, applying intensive, self-directed and diversified knowledge of engineering and quality principles and practices for implantable medical devices and accessories. This individual works with other employees within quality to ensure objectives and approaches to significant organizational projects or assignments align with the companies.

Essential Functions:

• Applies knowledge of QSR and GMP requirements on a daily basis

• Establishes and Maintain Receiving Inspection procedures to support product and receiving inspections

• Write, review and/or approve validation plans, protocols and reports (e.g., cleanroom, equipment) in accordance with applicable regulatory requirements and Globus SOPs

• Analyzes data and perform statistical analysis to ensure validation meets predefined acceptance criteria.

• Collaborates with cross functional teams in Costa Rica, and Redwood City, CA to implement and align Quality Control inspection plans, requirements, and methodologies

• Provides guidance to manufacturing processes and personnel

• Works with cross-functional team to implement comprehensive preventative maintenance work instruction as well as revalidation requirements

• Works with production and inspection staff to analyze, evaluate, understand and resolve any assembly inconsistencies or product/production issues

• Reviews and dispositions Non-conformance reports. Perform Root Cause analysis in order to determine corrective and preventive action activities

• Ensures appropriate process outputs and process controls are translated into Quality Control Plans, Work Instructions and Device Records

• Evaluates risk, manage risk assessment activities and create associated documentation

• Investigates and implements solutions to internal and external audit findings

• Leads Supplier management and Supplier Quality activities for local suppliers

• Collaborates with Suppliers, as appropriate to identify and define corrective actions and follow-up to ensure completeness and effectiveness of Supplier improvements to meet copy and applicable regulatory requirements

• Participates in audits (internal & external) and regulatory agency inspections

• Responsible for reviews/releases of Batch Record(s) and review of other documentation from medical device manufacturing and packaging suppliers, and ensure that all activities comply with quality requirements and company procedures

• Performs Quality assessment of changes to manufacturing processes, materials, and procedures and ensure applicable and appropriate documentation are generated

• Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies

• Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role

• Represents the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Qualifications:

• Bachelor’s degree in relevant technical discipline required; advanced degree preferred

• Equivalent years of experience may be substituted for education requirement

• No fewer than four (4) years of directly related experience, with at least two (2) of those years in a class II or III medical device environment, preferably in implantable device

• Experience in the medical device industry and with extensive knowledge performing their function within the Food & Drug Administration (FDA), Quality