Quality manager


Salario confidencial CRC

Toda Costa Rica

Publicado 17 Sep 2021

Gerencia gral: presidencia / Otras

1 Vacante

Ingeniería Industrial / Otras

Sector de la vacante:

Descripción general

Position Objective

Responsible for coaching and directing their assigned site quality team in establishing, maintaining and improving the business unit’s quality system according to regulatory and company requirements.

Main Responsibilities
• Establishes and maintains adequate quality systems, policy, objectives, and metrics and ensures resources are adequate, appropriate and competent to support the quality system to ensure quality and reliability of products and services supplied by their business unit.
• Ensures compliance of their business unit’s quality system to ISO 13485 and government regulations in marketed jurisdictions
• Serves as Management Representative for their business units quality system.
• Develops and deploys Quality strategies that are aligned with business strategy across areas of responsibility to continuously improve product and service quality performance.
• Provides technical support for the manufacture of existing products and the growth and development / transfer of new products / technologies.
• Ensures the continued effectiveness and compliance of products manufactured from their assigned areas.
• Participates in the development of long-term strategic plans across their assigned business unit.
• Champions the quality culture and builds outstanding partnerships with operations, supply chain, manufacturing, regulatory, research and development, sales, and other functions.
• Develops quality capabilities, training and coaching for their team and rest of company as applicable; Build future leaders for the organization.
• Makes critical, creative and strategic decisions as a result of analysis of available information including risk-assessment for the patient and for the business.
• Develops and executes on annual budgets and department plans.
• Adhere to and promote the adherence to all Corporate, Quality and Health and Safety policies and procedures.
• They ensure quality system performance for their business unit i

Requisitos para aplicar

Knowledge and Experience:
• Minimum Bachelor’s degree in a scientific or engineering discipline required.
• Advanced English proficiency (85%)
• 5 years of experience working in Medical industry or manufacturing environment.
• At least 2 years of experience leading quality projects or teams.
• Experience working with U.S. FDA regulations, ISO 13485 Quality System Standar and ISO 14971 Risk Management.
• Working knowledge of the Medical Devices Directive (93/42/EEC) and MDSAP requirements including Canadian Medical Device Regulation (CMDR), Brazil ANVISA, Australian MDR and JPAL/JGMP requirements an asset.

Datos complementarios




Bachillerato universitario

Manufacturas varias / Otros

5 años de experiencia

Contrato Indefinido


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