Globus Medical Quality Assurance Specialist in Audubon, Pennsylvania
At Globus, we move with a sense of urgency to deliver innovations that improve the quality of life of patients, inspired by the surgeons and healthcare providers who treat them.
Our world-class engineering works to transform clinical insights into tangible musculoskeletal solutions. We are constantly in pursuit of better patient care, and we understand that speed is critical because life cannot wait. Join us!
The Quality Assurance Specialist will work within the Quality Assurance department to provide review of device/product records to ensure compliance to applicable federal, state, local, and accreditation standards. The QA Specialist will audit Device Master Records (DMR), Design History Files (DHF) and Device History Records (DHR) for compliance and release criteria. The position will also assist with compliance activities of the Globus quality system and participate in continuous improvement activities.
The responsibilities of the position include, but are not limited to, the following:
Performing Device History Record review and release functions
Auditing Design Master Records and Design History Files
Reviewing certificates of compliance or test reports; Reviewing technical and performance specifications
Participating in continuous improvement functions and implement changes for improvement
Reporting non-conformances and discrepancies
Creating formal audit reports
Reviewing receiving inspection documentation
Generating Excel Spreadsheets to provide weekly metrics for Quality and Compliance management to review
Adhering to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies. Ensure 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
Representing 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 of Globus
In order to be qualified for this role, you must possess the following:
Bachelor’s Degree preferably in a field of Science or equivalent/applicable experience
1-3 years’ experience performing file reviews and/or audits; QA or QC experience within the biotech industry preferred
Experience with GMP regulations
Proficient with Microsoft Word and Excel programs
Proven ability to evaluate and interpret technical data; audit experience preferred
Strong typing skills, analytical skills, and problem-solving techniques
Excellent communication and writing skills
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.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
Globus Medical 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.