Faça parte de algo maior na BD.Aqui, você nos ajudará a melhorar continuamente a forma como fazemos as coisas todos os dias; para ser mais eficiente, mais eficaz e melhor servir os nossos clientes. Você fará isso dentro de uma equipe excepcional, todos se esforçando para garantir que tudo o que fazemos esteja em conformidade com os regulamentos e padrões, não apenas porque é a coisa certa a fazer, mas porque nossos produtos afetam a qualidade de vida das pessoas. Aqui, você colocará sua experiência em conformidade, altas expectativas e atenção aos detalhes da melhor maneira possível: Impulsionar o mundo da saúde™. Na BD, você pode fazer a verdadeira diferença de um.
Responsabilidades
Job Description Summary
Performance QA activities to ensure compliance with applicable standards and medical device regulatory requirements. Contributes to the completion of specific programs and projects usually under the direction of a project leader. Excellent understanding of applicable standards and regulations and industry practices with good auditing skills. Works under general direction while independently determining and developing approaches to solutions. Frequent inter-organization contacts to achieve stated objectives.Job Description
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. The company develops innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD has 70,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
“BD, a 125-year-old global medical device company has started its Enterprise Center in Bangalore, India called BD Technology Campus India (TCI). This Enterprise Center will be an integral part of the global network for BDX. It will have presence of R&D, Quality, Regulatory, IT and other functions. The center boasts of some of the brightest minds who work in a unique environment that fosters and supports ingenuity. BD TCI is dedicated to serving BD’s customers and patients thereby contributing its bit towards “advancing the world of health”.
Job Responsibilities:
- Leads QS activities, including the following:
- Ensures regulatory compliance for all aspects of QS processes.
- Leads internal audit program.
- Leads preparation of Quality Management Review material, prepares and shares meeting minutes and action items. Ensure timely completion of action items.
- Leads planning and scheduling of QMS activities.
- Lead the organization in third-party quality audits, ensure availability of documentation by following war-room concept, closes the loop with external auditors on audit reports, action plan, etc.
- Authors, reviews, and provides input for QS documents to ensure compliance with QSR, ISO and EN requirements.
- Understands post-market surveillance and complaint handling process.
- Provides QS knowledge to organization as needed. Administers appropriate training, as needed.
- Reviews and improves existing quality procedure workflows and identifies areas of improvement for efficiency.
- Shall independently author concise quality investigation reports with appropriate corrective action and preventive action identified.
- Ensures document and record control per applicable standards and procedures
Education:
- Bachelor’s degree in engineering or related discipline
Experience:
Minimum 4 years of professional experience
Knowledge:
- Good working knowledge and auditing experience of medical device regulations and practices (ISO13485, FDA, QSR, etc.)
- Fair understanding of QA principles, concepts, industry practices and standards. General knowledge of related technical disciplines
Skills:
- Minimum 4 years relevant experience in quality management system and GDP compliance
- Disciplined and well-organized in documentation
- Team player with excellent interpersonal and communication skills
- Proven ability to work independently with a minimum of supervisor input.
- Demonstrated ability to quickly learn new subject matter.
- Strong critical thinking
- Excellent communication and writing skills.
Additional Skills (Not essential but will be an advantage):
- Certified as a ISO13485 Lead Auditor
Trained on 21CFR 820 requirements and ISO14971.
Required Skills
Optional Skills
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Primary Work Location
IND Bengaluru - Technology CampusAdditional Locations
Work Shift
Perfil de Sucesso
What makes a successful Quality Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.
- Ambicioso
- Colaborativo
- Orientado para Objetivos
- Persuasivo
- Resultados
- Iniciador
Impulsionando o mundo da saúde™
BD é uma das maiores empresas globais de tecnologia médica do mundo e está Impulsionando o mundo da saúde™ melhorando a descoberta médica, o diagnóstico e a entrega de cuidado. A BD ajuda os clientes a melhorar os resultados, reduzir custos, aumentar a eficiência, melhorar a segurança e expandir o acesso aos cuidados de saúde.