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.
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Tipo:
Em tempo integral -
Trabalho Nível:
Sênior -
Viagem:
Varia -
Salário:
Competitivo -
Responsabilidades
Job Description Summary
About BDBD 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”.
Position Summary
Performs Post Market Surveillance (PMS) activities to ensure compliance with applicable medical device regulations.Ensures data collection, compilation, cross-functional reviews, and final release of PMS Plans, PMS Reports, and PSURs per EU MDR and regional regulatory requirements. Works under general direction while independently determining and developing approaches to solutions, with frequent inter-organization collaboration required.
Educational Background
Bachelor’s degree in engineering, or a technical discipline.
Professional Experience
3+ years of relevant experience required, preferably in the Medical Device / Healthcare Industry
Job Responsibilities
Supports PMS process in accordance with EU MDR 2017-745 and regional regulations.
Compiles device-based PMS Plans, PSUR and regional PMS reports, ensuring consistency and accuracy in information, data analysis, content and layout, spelling, grammar, punctuation, and compliance to regulation and procedure.
Works collaboratively with the cross-functional teams to meet all specified requirements and timelines, supporting multiple projects simultaneously.
Supports internal/external audits and related assignments.
Supports continuous improvement objectives for Quality Systems and Post Market Surveillance organization.
Administers appropriate PMS training as needed.
Participates in the ongoing operations of QA/QS activities and performs related duties as assigned.
Knowledge and Skills
Knowledge
Knowledgeable in medical device post market surveillance and risk management regulations and practices (EUMDR 2017-745, ISO 13485, ISO 14971, FDA QSR, etc.)
Proficient in data analytics with demonstrated experience in Microsoft Power BI and Microsoft Excel.
Excellent technical writing skills. Disciplined and well-organized in documentation, with high proficiency level required in Microsoft Word and Adobe Acrobat.
Working knowledge of Good Documentation Practices in prior roles.
Skills
Team player with excellent interpersonal and communication skills, with ability to review and work through complexities in a methodical manner.
Fluent in English language (spoken and written) as the main mode of communication across teams and functions.
Strong critical thinking, analytical, and problem-solving skills.
Desired / Additional Skills & Knowledge (Not essential to the job but will be an advantage to possess)
Familiarity with Microsoft Vizio application.
Any additional Information (Specially if needed for Quality or legal purposes)
N/A
Job Description
P2-14200
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”.
Position Summary
Performs Post Market Surveillance (PMS) activities to ensure compliance with applicable medical device regulations. Ensures data collection, compilation, cross-functional reviews, and final release of PMS Plans, PMS Reports, and PSURs per EU MDR and regional regulatory requirements. Works under general direction while independently determining and developing approaches to solutions, with frequent inter-organization collaboration required.
Educational Background
Bachelor’s degree in engineering, or a technical discipline.
Professional Experience
3+ years of relevant experience required, preferably in the Medical Device / Healthcare Industry
Job Responsibilities
Supports PMS process in accordance with EU MDR 2017-745 and regional regulations.
Compiles device-based PMS Plans, PSUR and regional PMS reports, ensuring consistency and accuracy in information, data analysis, content and layout, spelling, grammar, punctuation, and compliance to regulation and procedure.
Works collaboratively with the cross-functional teams to meet all specified requirements and timelines, supporting multiple projects simultaneously.
Supports internal/external audits and related assignments.
Supports continuous improvement objectives for Quality Systems and Post Market Surveillance organization.
Administers appropriate PMS training as needed.
Participates in the ongoing operations of QA/QS activities and performs related duties as assigned.
Knowledge and Skills
Knowledge
Knowledgeable in medical device post market surveillance and risk management regulations and practices (EUMDR 2017-745, ISO 13485, ISO 14971, FDA QSR, etc.)
Proficient in data analytics with demonstrated experience in Microsoft Power BI and Microsoft Excel.
Excellent technical writing skills. Disciplined and well-organized in documentation, with high proficiency level required in Microsoft Word and Adobe Acrobat.
Working knowledge of Good Documentation Practices in prior roles.
Skills
Team player with excellent interpersonal and communication skills, with ability to review and work through complexities in a methodical manner.
Fluent in English language (spoken and written) as the main mode of communication across teams and functions.
Strong critical thinking, analytical, and problem-solving skills.
Desired / Additional Skills & Knowledge (Not essential to the job but will be an advantage to possess)
Familiarity with Microsoft Vizio application.
Any additional Information (Specially if needed for Quality or legal purposes)
N/A
Required Skills
Optional Skills
.
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.