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Quality Supervisor (608663)

Quality Supervisor (608663)
Empresa:

Zimmer Biomet


Lugar:

Guaynabo

Detalles de la oferta

Responsible for overseen, defining, maintaining, implementing, and monitoring quality assurance activities to ensure the manufacturing process and product quality in compliance with established product design and process specifications. Chairperson of designated DMRRs Material Review Board (MRB). Supervision of personnel performing product and process quality inspection, verification and/or testing and personnel responsible for manufacturing quality monitoring and trend analysis in compliance with QMS and regulatory requirements. Principal Duties and Responsibilities•Coordinates product/process required inspections, testing, verifications and/or audits in accordance with established procedures. Distribute, allocate and keeps load balance among Quality Inspectors in order to ensure proper monitoring of all manufacturing and supporting areas. Ensure that inspections are being made in accordance with established procedures and following recognized Quality Standards. Active participation on the product realization process activities related to components/product and manufacturing process verifications. Review, evaluate, disposition and/or release of processes, components, manufacturing materials, assemblies, and/or product not conforming to established specifications or requirements. Conduct regular MRB meeting for proper and timely review of DMRRs (Discrepant Material Review Requests). Active participation of required Vendor Notifications associated with incoming material non-conformances including corrective actions recommendations and monitoring of effectiveness of implemented actions. Review, analyze and revise Quality Inspection Reports in order to identify actual or potential unfavorable trends and/or opportunities for improvements. Elevate the related trend information including recommendations for evaluation and/or possible incorporation within the CAPA system. Review, analyze and revise Product and Environmental Testing Results in order to identify actual or potential unfavorable trends and/or opportunities for improvements. Elevate the related trend information including recommendations for evaluation and/or possible incorporation within the CAPA system. Ownership of CAPA's related to nonconformance of Quality Inspection/Verification processes. Planning and coordination of Product and Environmental sampling required for outsourced Lab Testing in accordance with established procedures. Compilation, review and approval with records and documentation required for the release of Product Sterilization Batches (Gamma and EO). Maintaining the Training Certification of Quality, Manufacturing, Warehouse, and Shipping personnel Training/Certification to ensure affectivity and validity of product/process related trainings in accordance with established procedures. Reviews reports and confers with quality assurance, production, management, and engineering personnel to solve work-related problems. Provides information to supervisors related to individual quality performance to be used as inputs for personnel evaluations. Issue, review and reporting of Quality Inspectors and Technicians performance appraisals on regular basis ensuring proper feedback to allow performance improvements as necessary in compliance with established company policies. Definition, maintenance and provision of Quality Inspectors and Technicians job training in order to ensure the required proficiency level to perform the assigned tasks and responsibilities accurately, effectively and efficiently. Review and/or revision of Inspections, Verifications, and/or Testing Procedures ensuring compliance with current process and applicable standards. Oversees manufacturing and supporting areas processes/operations ensuring compliance with established policies, procedures, work instructions, ISO 13485, FDA QSR, and any other applicable regulatory requirements related to Biomet Quality System. Performs related duties as required Supervisory Responsibilities: QA Technician, QA Inspector, Quality Record Technician Expected Areas of CompetenceTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Language Skills: Bilingual-(English and Spanish) Ability to read and interpret documents such as price lists, catalogs, requisitions, vendor quotes and invoices, and engineering drawings. Ability to write routine reports and correspondence. Ability to speak effectively to vendors and employees of the organization. Mathematical Skills: Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry. Background statistical knowledge. Reasoning Ability: Attention to detail. Excellent negotiation and communication skills. Must be able to manage multiple short and long-term projects simultaneously. Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. oMobility: (Ability to assist in the movement of objects) Sitting• Walking • Standing oDexterity: (Ability to manipulate objects) Reaching • Grasping oVisual: (Ability to recognize, register, and respond) Reading / Close-up work Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate. Education/Experience Requirements•Bachelor\'s Degree in Science, Engineering or a related technical discipline is preferred. Five years in medical devices industry or related field. Three year supervision experience. Knowledge in FDA regulations, cGMPs, Quality System Regulations, ISO Standards, industry standards, and country specific standards that may be applicable (Canada, Japan, Australia, Brazil, etc.) and relevant to the manufacture of pharmaceuticals. Process and systems experience in SOPs, WIs and Change Controls is required. Control, Evaluation and Disposition of Nonconforming Materials (MRB). Statistics & process control understanding and execution. Non-Conformance Investigation and CAPA experience is required. Process, testing methods (USP, EPA SM, ISO, etc) and release knowledge of Water Systems, Cleanroom & Environmental Control, and Product Sterilization prefered. Previous Validation Experience is preferred. Organizational, communication/interpersonal and facilitation skills (verbal, written and presentation). This candidate must have excellent problem solving skills and must demonstrate expertise in handling multiple priorities simultaneously. Proficient with Microsoft office Suite Computer System experience in MAPICS and XA Infor is preferred. Any other duty Travel RequirementsUp to 10% [ SDL2017


Fuente: Adzuna_Ppc

Requisitos


Conocimientos:
Quality Supervisor (608663)
Empresa:

Zimmer Biomet


Lugar:

Guaynabo

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