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.
Position Summary:
The Quality Assurance Specialist (QAS) will work within the Quality Assurance department to provide review of device/product records to ensure compliance to applicable federal, state, local, international and accreditation standards. The QAS will perform Internal Quality Audits, Perform Supplier Audits, audit Device Master Records (DMR), Design History Files (DHF) and Device History Records (DHR) for compliance and release criteria. The QAS will also contribute to compliance activities of the Globus quality system and participate in continuous improvement activities. The position responsibilities may include the following, although other duties and responsibilities may be assigned as necessary.
Essential Functions:
Performs Internal Quality Audits
Performs Supplier Audits
Audits Device Master Records and Design History Files
Reviews certificates of compliance or test reports
Reviews technical and performance specifications
Reviews receiving inspection documentation
Reports non-conformances and discrepancies
Generates Excel Spreadsheets
Participates in continuous improvement functions and implement changes for improved
Other duties and responsibilities as necessary
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
Medical Device experience is a MUST
Experience performing file reviews and/or audits
QA or QC experience within the biotech industry preferred
Knowledge of GMP regulations preferred
Must be knowledgeable with Microsoft word and Excel programs
Must have ability to evaluate and interpret technical data
Must be able to lift at least 25 lbs
Strong typing skills, analytical skills, and problem-solving techniques
Excellent communication and writing skills
Physical Demands:
The physical demands listed here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Required to sit; climb or balance; and stoop, kneel, crouch or crawl
Required to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds
Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus
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.