The posting
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.
Nevro Corp., a subsidiary of Globus Medical Inc., is a global medical device company focused on delivering comprehensive, life-changing solutions that continue to set the standard for enduring patient outcomes in the treatment of chronic pain. Nevro’s comprehensive HFX™ spinal cord stimulation (SCS) platform includes the Senza® SCS system and support services for the treatment of chronic pain of the trunk and limb and painful diabetic neuropathy. Nevro also provides minimally invasive treatment options for patients suffering from chronic sacroiliac joint pain.
Position Summary:
The Quality Control Inspector is responsible for performing inspections at various stages of production of the product from raw material. This effort includes, but is not limited to, providing QA support, where needed, but not limited to QA Operations. This individual works with other quality control inspectors and engineers to ensure products or assignments align with the companies.
Essential Functions:
- Carries out inspection activities to ensure the quality of products and raw materials used in the production of products to meet customer or internal standards
- Responsible for the correct handling of the corresponding fixtures and equipment
- Correct use of quality inspection records following GMP requirements
- Ensures the consistency and quality of records by editing and proofreading all documentation prior to handling it to the documentation center for storage
- Maintains and archives documents in an organized and retrievable state (manual or electronic) for compliance to procedures, regulations and standards
- Safekeeping all quality records of In-Process Inspection
- Schedules periodic document reviews to ensure documents are compliant with Globus requirements and processes as well as external regulations
- Communicates corrections and improvement opportunities
- Ensures timely release of subassemblies and assemblies by executing, reviewing and approving Device History Records (DHRs) and ERP transactions per internal requirements
- Responsible for the control of nonconforming material (identification, segregation)
- Interfaces with cross functional team to ensure internal and external compliance requirements are followed and implemented per requirements
- Labels and segregates components and assemblies
- Notifies cross functional departments including Production, Quality and Purchasing on component/assembly dispositions and/or material holds
- Manages component/assembly disposition and queries using the QAD system
- Supports with External Audits activities when required and as directed
- Responsible for the release of subassemblies, assemblies and final assemblies
- 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:
- Quality Inspector or advanced studies in relevant technical discipline required
- No fewer than three (3) years of directly related experience, having experience in a class II or III medical device environment quality inspection is preferred, complaints lab inspection or receiving inspection is also preferred, inspection small components using a microscope is preferred
- Experience in the medical device industry and with knowledge performing their function within the Food & Drug Administration (FDA), Quality System Regulations (QSRs), International Organization of Standardization (ISO 13485) is preferred
- Experience with QAD preferred
- Prior experience working with US companies is a plus
- IPC-A-610 certification or knowledge in medical device component welding through resistance welding, spot welding or laser welding is a plus
- Handling of electrical components is a plus
- Experience with ESD processes is a plus
- Ability to read and interpret documents such as job travelers, plans, sketches, diagrams and other procedural materials and documents
- Fundamental geometry, fractions, percents, relationships and measurements
- Ability to work independently with little supervision, as well as in "team" work
- Effective interpersonal skills and dexterity on the job with a culturally diverse employee population
- Knowledge of measurement instruments, sample plans is a plus
- Experience with inspecting small parts under magnification is a plus
- Work environment and physical requirements:Production area / clean room Some exposure to noisy equipment
- Strong organizational and follow-up skills
- Excellent verbal and written communication skills
- Attention to detail
- Self-starter
- Advanced critical thinking and problems-solving skills
- Proficiency in using Microsoft Office products
Physical Demands:
The physical demands listed here are representative of those that must be met by and 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 25 pounds, and occasionally lift and/or move up to 50 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.
