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.

  • Tipo:
    Em tempo integral
  • Trabalho Nível:
    Sênior
  • Viagem:
    Varia
  • Salário:
    Competitivo
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Responsabilidades

Job Description Summary

Job Description

About BD

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.

About BD TCI

“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 Summary:

We are seeking a skilled Senior Quality Assurance & Data Analyst to join our Quality team. The ideal candidate will have a strong background in digitizing processes and developing innovative solutions, with experience in the medical device industry being a plus. This role involves collecting, analyzing, and interpreting complex data to support decision-making and improve operational efficiency. Additionally, the candidate will perform QA activities to ensure compliance with applicable standards and medical device regulatory requirements.

Key responsibilities include contributing to the completion of specific programs and projects, usually under the direction of a project leader. The candidate must have an excellent understanding of applicable standards, regulations, and industry practices, along with strong auditing skills. Working under general direction, the candidate will independently determine and develop approaches to solutions, maintaining frequent inter-organization contacts to achieve stated objectives.

Job Responsibilities:(Primary Duties, Roles, and/or Authorities)

Quality Systems (QS) Activities:

  • Lead QS activities, ensuring regulatory compliance for all aspects of QS processes.
  • Lead internal audit programs and preparation of Quality Management Review materials.
  • Plan and schedule QMS activities, ensuring timely completion of action items.
  • Lead third-party quality audits, manage documentation, and close the loop with external auditors.
  • Author, review, and provide input for QS documents to ensure compliance with QSR, ISO, and EN requirements.
  • Understand post-market surveillance and complaint handling processes.
  • Provide QS knowledge and administer appropriate training as needed.
  • Review and improve existing quality procedure workflows, identifying areas for efficiency enhancement.
  • Independently author quality investigation reports with appropriate corrective and preventive actions.
  • Support internal and external regulatory inspections and audits.
  • Train, develop, and provide relevant technical guidance to cross-functional team members.

Data Analysis:

  • Collect, clean, and analyze data from various sources to identify trends and insights for Quality systems enhancements.
  • Develop and implement data digitization processes to streamline Quality operations.
  • Create and maintain dashboards and reports to effectively visualize data and communicate findings to stakeholders.
  • Collaborate with cross-functional teams to develop innovative solutions based on data analysis.
  • Provide actionable recommendations to improve business processes and drive strategic initiatives.
  • Ensure data accuracy and integrity by implementing best practices in data management.

Education and Experience:

Education:

  • Bachelor’s degree in engineering or related discipline

Experience:

  • Minimum 4 to 6 years of professional experience

Knowledge and Skills:

  • 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
  • Proven experience in digitizing processes and developing innovative solutions.
  • Strong analytical skills with the ability to interpret complex data sets.
  • Proficiency in data visualization tools (e.g., Tableau, Power BI) and statistical software (e.g., Minitab, R, Python).
  • Excellent communication skills to present findings and recommendations effectively.
  • Experience in the medical device industry is a plus.
  • Ability to work independently and collaboratively in a fast-paced environment.

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

.

Primary Work Location

IND Bengaluru - Technology Campus

Additional Locations

Work Shift

Candidatar

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.

A BD é única em quão totalmente dedicado é a um estado de doença específico. Deixa claro como o trabalho que fazemos impacta diretamente a vida diária dos pacientes que atendemos.


Eric Rainis
Diretor Sênior de Gestão de Qualidade

Saber que nossos produtos atingem 30 milhões de pessoas com diabetes em todo o mundo é poderoso e estimula nossas equipes a fornecer os melhores produtos da categoria a eles todos os dias.


Bridget Bagnato
VPGM Injection

É inspirador ver os produtos BD serem usados globalmente para promover a saúde humana.


Yang Zeng
Laboratório Médico

BENEFÍCIOS

Healthcare

401(k)/
Planos de Aposentadoria

Desenvolvimento Profissional

Licenças Remuneradas

Prêmios e
Reconhecimentos

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