Quality Control Inspector I
Globus Medical
Quality Control InspectorBranch Medical Group, a subsidiary of Globus Medical Inc., manufactures a wide range of implants for spinal and orthopedic applications as well as design the instrumentation cases that house them. Our passion, combined with Globus' world-class engineering, transforms clinical insights into tangible musculoskeletal solutions. We are constantly in pursuit of better patient care and understand that speed is critical because life cannot wait.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 standardsResponsible for the correct handling of the corresponding fixtures and equipmentCorrect use of quality inspection records following GMP requirementsEnsures the consistency and quality of records by editing and proofreading all documentation prior to handling it to the documentation center for storageMaintains and archives documents in an organized and retrievable state (manual or electronic) for compliance to procedures, regulations and standardsSafekeeping all quality records of In-Process InspectionSchedules periodic document reviews to ensure documents are compliant with Globus requirements and processes as well as external regulationsCommunicates corrections and improvement opportunitiesEnsures timely release of subassemblies and assemblies by executing, reviewing and approving Device History Records (DHRs) and ERP transactions per internal requirementsResponsible 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 requirementsLabels and segregates components and assembliesNotifies cross functional departments including Production, Quality and Purchasing on component/assembly dispositions and/or material holdsManages component/assembly disposition and queries using the QAD systemSupports with External Audits activities when required and as directedResponsible for the release of subassemblies, assemblies and final assembliesAdheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policiesEnsures 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 roleRepresents 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 partiesReasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.Qualifications:Quality Inspector or advanced studies in relevant technical discipline requiredNo 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 preferredExperience 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 preferredExperience with QAD preferredPrior experience working with US companies is a plusIPC-A-610 certification or knowledge in medical device component welding through resistance welding, spot welding or laser welding is a plusHandling of electrical components is a plusExperience with ESD processes is a plusAbility to read and interpret documents such as job travelers, plans, sketches, diagrams and other procedural materials and documentsFundamental geometry, fractions, percents, relationships and measurementsAbility to work independently with little supervision, as well as in "team" workEffective interpersonal skills and dexterity on the job with a culturally diverse employee populationKnowledge of measurement instruments, sample plans is a plusExperience with inspecting small parts under magnification is a plusWork environment and physical requirements:Production area / clean roomSome exposure to noisy equipmentStrong organizational and follow-up skillsExcellent verbal and written communication skillsAttention to detailSelf-starterAdvanced critical thinking and problems-solving skillsProficiency in using Microsoft Office productsPhysical 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 crawlRequired to regularly lift and/or move up to 25 pounds, and occasionally lift and/or move up to 50 poundsRequired 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 about 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.
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