Senior Biological Product Safety Specialist

vor 2 Wochen

Kloten, Schweiz Envista Holdings Vollzeit

Job Description:

We are recruiting a Senior Biological Product Safety Specialist based in our Headquarter in Zurich (Switzerland) or in our Manufacturing in Karlskoga (Sweden) focusing on the correlation between manufacturing processes and final product chemical cleanliness. He/She will be responsible for translating and linking in-process and final product chemical cleanliness requirements with the necessary standards for biological safety in both validation and routine production.

The main responsibilities:

Execution pipeline and life cycles activities

  • Evaluating biocompatibility according to international standards (e.g. ISO 10993, FDA guidances) and Nobel Biocare’s processes on the entire product portfolio
  • Performing risk assessments, designing biological evaluation strategies, monitoring external testing, and issuing biological evaluation plans and reports within New Product Introduction Projects as well as for the entire life-cycle of the portfolio.
  • Subject Matter Expert in providing scientific input, justifications, rationales, and clarifications to global regulatory submissions (MDD, MDR, FDA, PMDA, NMPA etc.), marketing, product management, and other stakeholders.
  • Supporting biological product safety during internal and external audits.
  • Planning and managing the impact assessment of manufacturing, supplier, design, and material changes to medical devices to ensure product safety and sustainability.
  • Remaining up-to-date with changes in technologies, academic research, standards, and regulatory policies regarding biocompatibility.
  • Performing literature reviews and presenting the results at internal steering meetings and external events.
  • Conducting gap analyses to new standards or version changes of existing standards and guidelines; and implementing identified actions.
  • Knowledge of design control process requirements and requirements for technical documentation for medical devices.
  • Able to put together a plan for the different tasks within a project (e.g. NPI), identifying gaps and improvements.
  • Ensuring the final products meet the cleanliness specifications in regards to the level of (physical/chemical) contaminants.
  • Supporting the definition of process validation study in regards to physical/chemical cleanliness on new or updated equipment.
  • Ensuring stable product and process output for biocompatibility by supporting the definition of monitoring concepts in regards to physical/chemical cleanliness.

Process improvements, coaching, and leadership

  • Periodic review and update of procedures and templates including training.
  • Maintaining and extending a global network of external analytical partners (analysis labs, universities, research institutes) to complement and enhance internal capabilities.
  • Providing guidance to new team members.
  • Attending and learning from others' training.
  • Solving problems in challenging situations; analyzing possible solutions using technical experience.

General

  • Supporting strategy development and execution according to Envista and Nobel Biocare priorities and targets.
  • Executing all activities according to Envista’s integrity and compliance standards and programs. Showing awareness of the impact of ethical behavior by ensuring integrity in personal and organizational practices; respecting people and principles, including professional, ethical, and human values.
  • Raising and escalating potential organizational ethics and compliance issues.
  • Impacting the quality of own work and the work of others on the team; working within guidelines and policies.
  • Understanding key business drivers; using this understanding to accomplish own work.

Job Requirements:

Critical Knowledge and Qualifications:

  • Strong technical background (MSc or equivalent) in a relevant field (Biotechnology or Biomedical Engineering, Toxicology, Biology, Chemistry, or related science).
  • Understanding of ISO 10993 biocompatibility standards.
  • Broad understanding of ASTM F3127-22, ASTM F2847-17.
  • Broad understanding of manufacturing environment and process validation.
  • Understanding of ISO 13485 and ISO 14971.
  • Understanding of bone and/or mucosa biology, pharmacology, and biochemistry.
  • Fluent in English (spoken and written); German (spoken and written) is an asset.

Critical Skills/Technical Know-how:

  • A systematic and result-oriented work style.
  • Good knowledge in relevant tools (SAP, MS Office), processes (DCP and ItM), and relevant SOPs.
  • Good internal knowledge of the relevant Nobel Biocare products, their materials, manufacturing methods, and limitations.
  • Strong analytical skills.
  • Pro-active and independent working style with a strong sense of responsibility and problem-solving attitude.

Critical Experience:

  • 5+ years of relevant experience working in a regulated environment, preferably in the Dental Medical Device Industry.
  • Experience working cross-functionally and in multi-cultural teams (matrix organizations).

Operating Company: Nobel Biocare

#J-18808-Ljbffr

  • Senior Biological Product Safety Specialist

    Vor 7 Tagen

    Kloten, Schweiz Envista Holdings Vollzeit

    Job Description: We are recruiting a Senior Biological Product Safety Specialist based in our Headquarter in Zurich (Switzerland) or in our Manufacturing in Karlskoga (Sweden) focusing on the correlation between manufacturing processes and final product chemical cleanliness. He/She will be responsible for translating and linking in-process and final...

  • Senior Product Development Engineer

    vor 2 Wochen

    Kloten, Schweiz Envista Holdings Corporation Vollzeit

    Senior Product Development Engineer page is loadedSenior Product Development EngineerApply locations Switzerland, Zurich, Kloten time type Full time posted on Posted 30+ Days Ago job requisition id R5020872Job Description:Nobel Biocare is seeking a highly motivated and skilled engineer who is passionate about driving new product developments to improve...

  • Senior Product Development Engineer

    Vor 7 Tagen

    Kloten, Schweiz Envista Holdings Corporation Vollzeit

    Senior Product Development Engineer page is loaded Senior Product Development Engineer Apply locations Switzerland, Zurich, Kloten time type Full time posted on Posted 30+ Days Ago job requisition id R5020872 Job Description: Nobel Biocare is seeking a highly motivated and skilled engineer who is passionate about driving new product developments to improve...

  • Product Development Specialist

    Vor 2 Tagen

    Kloten, Zürich, Schweiz Namespace Labs Vollzeit

    About Namespace LabsWe are a developer services company that provides high-performance cloud infrastructure for engineering teams. Our mission is to enable teams to ship better code faster.Our flagship product is a hosted cloud platform optimized for build and test workflows. This platform delivers capabilities and efficiencies unmatched by traditional cloud...

  • Senior Product Development Engineer, Kloten

    vor 2 Wochen

    Kloten, Schweiz TN Switzerland Vollzeit

    Client: EnvistaLocation:Job Category:-Job Reference:079c6a951297Job Views:12Posted:21.01.2025Expiry Date:07.03.2025Job Description:Job DescriptionNobel Biocare is seeking a highly motivated and skilled engineer who is passionate about driving new product developments to improve patients’ lives. As a Senior Product Development Engineer, you will play a...

  • Senior VMware Technical Specialist

    Vor 5 Tagen

    Kloten, Zürich, Schweiz IT Advanced Consulting SA Vollzeit

    We are seeking a highly experienced Senior VMware Technical Specialist to join our team at IT Advanced Consulting SA. As a key member of our technical leadership team, you will be responsible for providing technical guidance and expertise to our operations team, ensuring the smooth operation of our VMware infrastructure.Main Responsibilities:Technical...

  • Technical Laboratory Expert

    Vor 2 Tagen

    Kloten, Zürich, Schweiz SR Technics Group Vollzeit

    We are a leading provider of engine maintenance, repair, and overhaul services. As a Laboratory Specialist at SR Technics Group, you will be part of our team that ensures the highest level of quality and safety in our operations.The role involves technical responsibility for all laboratory services, ensuring compliance with agreed good laboratory practices...

  • Engineer - Chemical Analysis Specialist

    Vor 3 Tagen

    Kloten, Zürich, Schweiz SR Technics Group Vollzeit

    Job DescriptionWe are a world-leading engine MRO service provider, headquartered in Zurich, Switzerland, with over 90 years of operational experience.Our Mission: We safely power your flight. As a Laboratory Specialist, you will have technical responsibility for all provided services ensuring the methods and performance of chemical and physical as well as...

  • IT Infrastructure Specialist

    Vor 5 Tagen

    Kloten, Zürich, Schweiz Deutsche Bank Vollzeit

    Senior Designer Job DescriptionWe are seeking a highly skilled Senior Designer to join our team at Deutsche Bank. As a Senior Designer, you will play a critical role in managing and performing work across multiple areas of our IT Platform/Infrastructure.Responsibilities:Collaborate with stakeholders to gather and analyze business requirements, translating...

  • Quality Systems Specialist

    Vor 3 Tagen

    Kloten, Zürich, Schweiz 3Brain AG Vollzeit

    About 3Brain AGWe are a pioneering Swiss deep tech company working on cell-electronic interfaces that link biological networks to computers via custom-made semiconductor microchips. Our mission is to empower life scientists to probe intelligent networks, accelerate biomedical discoveries for the benefit of patients, and create a future more exciting than the...

  • Senior AI Data Specialist

    Vor 3 Tagen

    Kloten, Zürich, Schweiz Microsoft Vollzeit

    Job OverviewWe are on a mission to create the largest and most advanced multimodal dataset in the world, spanning all modalities from across the web and beyond. This dataset will power the training of the world's most capable AI frontier models, pushing the boundaries of scale, performance, and product deployment.About Our TeamWe are an interdisciplinary...

  • Senior Communications Specialist

    Vor 3 Tagen

    Kloten, Zürich, Schweiz JPMorganChase Vollzeit

    JPMorgan Chase is a global leader in financial services, providing strategic advice and products to prominent corporations, governments, wealthy individuals, and institutional investors. We strive to build trusted, long-term partnerships with our clients to help them achieve their business objectives.We are seeking a skilled Brand Development Associate to...

  • Contrail Reduction Specialist

    Vor 5 Tagen

    Kloten, Zürich, Schweiz Google Vollzeit

    As a Contrail Reduction Specialist, you will play a key role in developing and implementing strategies to reduce contrail formation in aviation. This includes working closely with the Google Research team that founded Project Contrails as well as the Google Flights team.The successful candidate will have a strong background in product management and a deep...

  • Digital Product Manager

    Vor 5 Tagen

    Kloten, Zürich, Schweiz Deutsche Bank Vollzeit

    Job OverviewWe are seeking a highly experienced Senior Designer to join our team at Deutsche Bank. The successful candidate will be responsible for managing and performing work across multiple areas of our IT Platform/Infrastructure.Key Responsibilities:Business Analysis: Collaborate with stakeholders to gather and analyze business requirements, translating...

  • Senior Production Operations Manager

    Vor 3 Tagen

    Kloten, Zürich, Schweiz 3Brain AG Vollzeit

    About 3Brain AGWe are a pioneering Swiss deep tech company working on cell-electronic interfaces that link biological networks to computers via custom-made semiconductor microchips. Our mission is to empower life scientists to probe intelligent networks, accelerate biomedical discoveries for the benefit of patients, and create a future more exciting than the...

  • Laboratory Specialist

    Vor 4 Tagen

    Kloten, Schweiz SR Technics Group Vollzeit

    We are a world leading Engine MRO service provider, headquartered in Zurich, Switzerland, with over 90 years of operational experience. Our unwavering dedication to innovation, excellence and environmental responsibility propels us forward on our journey to becoming the leading, most customer-centric, and sustainable Engine focused MRO worldwide.Working with...

  • Process Optimization Specialist

    Vor 5 Tagen

    Kloten, Zürich, Schweiz TN Switzerland Vollzeit

    We are seeking a skilled professional to join our team as a Process Optimization Specialist at TN Switzerland.Your key responsibilities will include:Developing, enhancing, and implementing systems that increase efficiency and optimize all phases of service or production processes, from design to manufacturing.Overseeing process design projects and ensuring...

  • Senior Solutions Designer

    Vor 5 Tagen

    Kloten, Zürich, Schweiz Deutsche Bank Vollzeit

    About the RoleWe are looking for a talented Senior Designer to join our team at Deutsche Bank. As a Senior Designer, you will be responsible for managing and performing work across multiple areas of our IT Platform/Infrastructure.Responsibilities:Collaborate with stakeholders to gather and analyze business requirements, translating them into detailed...

  • Retail Brand Marketing Specialist

    Vor 5 Tagen

    Kloten, Zürich, Schweiz On Vollzeit

    Company OverviewWe are a dynamic and innovative company, On, that is centered around growth and progress. Our mission is to create an environment that gives people the tools to develop holistically – to stay active, to learn, explore and innovate.About the RoleWe are seeking a highly skilled Retail Brand Marketing Specialist who will be responsible for...

  • Digital Asset Growth Specialist

    Vor 3 Tagen

    Kloten, Zürich, Schweiz Crypto Vollzeit

    About the RoleWe are seeking a highly motivated and results-driven Digital Asset Growth Specialist to join our team. In this role, you will be responsible for driving the growth and development of our core products, including Main App Trading, Loyalty Programs, VISA Card, and Pay.Key Responsibilities:Develop and execute strategic plans to drive commercial...