Quality Manager

Steris Corporation; Portugal; Presencial; EUR 70 000 - 110 000; Tempo integral

Resumo da oferta

A Steris Corporation procura um Quality Manager para liderar melhorias de qualidade em uma unidade de manufatura/serviços em Portugal. O(a) candidato(a) ideal terá forte presença no piso de produção, guiando equipes para manter o QMS, garantir conformidade com ISO 9001, ISO 13485 e CFR 820/211, e colaborar com produção para otimizar qualidade de produtos e serviços.

É exigida formação de Bacharel e 8–12 anos de experiência em manufatura/qualidade, com foco em ambiente ISO e habilidades de

Qualificações

• 8–12 anos de experiência combinada em Manufatura/Engenharia de Qualidade ou Sistemas de Qualidade.
• 8–12 anos em indústria médica ou regulada é preferível.
• Experiência em ambiente ISO e conformidade regulatória.
• Experiência mínima de 2 anos em liderança de qualidade.
• ASQ, QSR ou familiaridade com regulamentações QSR/GMP é preferível.
• Excelência em resolução de problemas e melhoria contínua.

Responsabilidades

• Conduzir a equipe de Qualidade para manter o QMS e impulsionar melhoria contínua.
• Alinhar qualidade com operações de manufatura, apoiando equipes de produção.
• Definir diretrizes estratégicas de qualidade e táticas da organização.
• Atuar como Representante de Gestão e liderar o processo de revisão de gestão.
• Gerir o relacionamento com fornecedores e assegurar conformidade regulatória.

Conhecimentos

Liderança de qualidade

Resolução de problemas

Colaboração multifuncional

Fluência em inglês

Análise

Comunicação

Formação académica

Bacharelado

Ferramentas

Excel

Word

PowerPoint

Visio

Descrição da oferta de emprego

Quality Manager

Empresa : Steris Corporation Tipo de Emprego : Periodo Integral Portugal

Descrição do Emprego - Quality Manager

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

Position Summary

The Quality Manager is responsible for leading quality improvement for a manufacturing or service facility/function, with a strong hands-on presence on the shop floor and close day-to-day collaboration with Production and Operations teams. This position leads implementing and maintaining state-of-the-art quality practices for associated product and service lines. The Quality Manager assumes overall responsibility in ensuring that the site maintains operational and quality systems in a state of compliance to domestic and international standards. The role is responsible for the organization, documentation and maintenance of the quality system to be compliant with, as appropriate, the following standards: IS0 9001, ISO 13485, MDSAP and CFR Part 820/211, EU MDR and other applicable standards. This role leads the local site efforts focused on product/service quality improvement, supplier quality, process quality, new product/service development quality and quality system compliance, while actively supporting manufacturing activities, addressing quality issues at their source. The Quality Manager serves as the Management Representative for the site(s) and is responsible for ensuring the quality system meets all applicable regulatory standards. The Quality Manager position requires a visible and proactive presence within production areas, partnering closely with manufacturing leaders and operators to ensure product quality, process effectiveness and regulatory compliance.

Duties

• Lead the organization’s Quality staff to ensure compliance to the overall Quality Management System and drive continuous improvement.
• Lead the organization’s Quality staff to ensure alignment to manufacturing and servicing operations, providing direct support to production teams, participating in daily operational activities, supporting Lean efforts and drive quality improvement for products and services.
• Work closely with site senior management and production leadership to provide strategic direction and development of the organization’s quality strategies and tactics.
• Provide quality viewpoints and opinions on future product and service development.
• Provide coaching, mentoring and leadership to the Quality staff.
• Serve as the site’s Management Representative and lead the organization’s Management Review process.
• Ensure compliance with appropriate domestic regulatory and international standards and requirements.
• Lead the organization's continuous improvement process; including data analysis, improvement projects and process capability to improve key metrics as measured by the product/service quality dashboard, with active involvement in production troubleshooting and process optimization activities.
• Lead and implement effective production and process controls, performing regular shop floor assessments, process observations and hands-on support to manufacturing teams to ensure sustainable compliance and process performance.
• Manage the complaint handling processes to insure customer responsiveness and product and process improvements, working directly with production personnel to identify root causes and implement corrective actions.
• Ensure compliance to the New Product Development process and assurance that the Product Requirements Document includes key quality performance metrics.
• Assess new designs for manufacturability, testability and reliability to ensure the Quality risks and deliverables of the New Product Development process meet the required application reliability and design intent.
• Determine supplier qualification risks based upon criticality of component and supplier process capability.
• The position requires a level of authority to conduct and direct required activities such as quality planning, personnel management and regulatory compliance.
• This individual has autonomy to perform the duties of Person Responsible for Regulatory Compliance (PRRC) on behalf of STERIS legal manufacturing entities under the EU MDR. This individual shall suffer no disadvantage within the organization in relation to proper fulfilment of his or her duties in lieu of article 15 of the EU MDR.

Education Degree

• Bachelor's Degree

Required Experience

• 8-12 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
• 8-12 years of experience with medical device or other regulated industries preferred.
• 8-12 years of experience working in an ISO certified environment required.
• Minimum of 2 years in a Quality leadership role.
• Must fulfil the experience requirements listed in Article 15 of the EUMDR (PRRC).
• ASQ, QSR or familiarity with QSR/GMP regulations preferred.
• Excellent problem-solving skills
• Focus on identification of potential issues and continuous improvement.
• Experience working on cross-functional teams and on own initiative, with demonstrated ability to collaborate effectively in a fast-paced manufacturing environment.
• Demonstrated excellent organizational, oral and written communications skills.
• Must have PC experience, as well as working familiarity of desktop applications including Excel, Word, and PowerPoint.
• Experience with statistical analysis software and Visio preferred.
• Strong hands-on approach with the ability to work effectively both on the shop floor and in office-based quality system activities.
• Strong proficiency in English

Working Conditions

• While physical activities are generally moderate, the role requires frequent presence in manufacturing areas for process observation, audits, investigations, operator interactions and support of production activities.
• Domestic travel required 10-20% of time

STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare and life sciences products and services around the globe. For more information, visit www.steris.com .

STERIS strives to be an Equal Opportunity Employer.