Quality Assurance Specialist

Globus Medical•Audubon, PA

13d

About The Position

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

Requirements

Bachelor’s Degree
Experience performing file reviews and/or audits
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, organizational skills and problem-solving techniques
Excellent communication and writing skills
Attention to detail
Self-starter

Nice To Haves

QA or QC experience within the medical device, biotech or other regulated industry. preferred
Knowledge of GMP regulations preferred

Responsibilities

Supports Lead Auditors and Audit Program Manager with audit management.
Performs Internal Quality Audits.
Performs Supplier Audits.
Supports Supplier File maintenance.
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 improvement.
Issue Quality System documents and coordinate training process.
Ensures documentation is complete, properly formatted and meets corporate standards.
Assist in assigning and tracking purchasing change requests from initiation through closure.
Performs database searches, data analysis, and reporting as required.
Organize and communicate status of work to management and other personnel as required and to keep them informed of objectives and progress.
Update and maintain Net Dimensions training system.
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 upholds the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties