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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 Operations Specialist will be responsible for performing Quality Operations testing, as specified below. This role will also be responsible for ensuring all policies and procedures are following applicable FDA, state, OSHA, AATB, and ISO regulations and standards.
Essential Functions:
Performs environmental monitoring, both routine and dynamic as well as non-viable monitoring.
Performs aseptic process monitoring.
Performs biological indicator testing.
Performs preventative maintenance on Quality equipment.
Document and process returned tissue (hct/p) product. This may include reworked product through Bone Bank Allografts.
Perform endotoxin testing and report out results to QA Review team.
Monitor all temperature and humidity sensors and alert appropriate department of OOS readings. Generate NCRs as required.
Complete testing to support validations (i.e. bubble leak, visual, visual peel, peel/burst)
Follows verbal and/or written instructions such as work instruction, and process specifications at the direction of manager in completing a variety of inspection tasks.
Document non-conformances when found.
Work efficiently to achieve targeted goals as set by management
Follow proper safety precautions.
Maintains the work areas in an organized manner
Familiarity with GMP and SOP's to ISO standards a plus.
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
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Qualifications:
High School diploma or equivalent required
Minimum two (2) years’ experience with quality control inspections is preferred
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 40 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.