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JOB TITLE QUALITY ASSURANCE MANAGER

São Paulo - São Paulo

Descrição da oferta de emprego

Job Title Quality Assurance Manager - The incumbent will ensure the Integrateam is aligned to execute key business deliverables with a commitment to quality. This leader shall demonstrate business quality acumen and sound decision making,would create an environment in which creativity and innovation are the norm andchange is not only accepted but encouraged by championing innovation and change. **Responsibilities**:% WEIGHTING OF RESPONSIBILITY 1ESSENTIAL DUTIES AND RESPONSIBILITIESTo perform this job successfully, an individual must be able to perform eachessential duty satisfactorily. Other duties may be assigned. 65%Establish and maintain a Quality Management System (QMS) for the ILS Korea site. Ensure that the QMS coincides with the Korean logistics provider''s processes andsystems, while also ensuring it is compatible with ILS Corporate and other ILSsites. Work with International Regulatory to understand the local regulations andensure the QMS are meeting these needs. 15%Establish processes for reporting (complaints and FSCA) that are compliant withthe local regulations and compatible with ILS Corporate processes. Ensurecomplaint decision tree processes are established and resources are in place toexecute. 10%Work with the local salesoperations and marketing teams to understand thebusiness needs for Korea, and how the quality team can help support these demands. 5%Work with other local distributors and work with Sales Operations to ensure theproper documentation (quality agreements, distribution authorization letters) arein place and active. 5%Other Duties as assigned**Qualifications**:The requirements listed below are representative of the knowledge, skill and/orability required for his position. EDUCATION:Bachelor''s degree in a scientific or engineering discipline with 7 years ofexperience in a regulated industry. EXPERIENCE:Prior experience with Medical Devices and Instruments is required. Working knowledge of appropriate global medical device regulations, requirements,and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971,European Medical Device Directive (93/42/EEC), MEDDEV 2. 12-1, European UnionMedical Device Regulation, KFDA Medical Device Act. DEMONSTRATED ABILITY TO:Develop and maintain key internal and external professional relationships. Generate results, enthusiasm, high levels of trust, commitment, and a sense ofurgency. Quickly gain the respect and support of own staff and fellow leaders. Build customer relationships with Integra LifeSciences? partners in order tofacilitate strong forecasting, product launch planning, and execution, and toensure effective customer problem resolutionExemplifies Leadership Integrity and CourageAbility to travel up to 10% of the Time
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Detalhes da oferta

Empresa
  • Caderno Nacional
Localidade
Endereço
  • Indeterminado - Indeterminado
Data de publicação
  • 20/12/2024
Data de expiração
  • 20/03/2025
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