Aktuelle Jobs im Zusammenhang mit Device Quality Management Systems Support Specialist - Basel, Basel-Stadt - Roche
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Global Quality Systems Data Scientist Specialist
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Device Development Specialist
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Device Development Specialist
vor 2 Monaten
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Device Development Specialist
vor 2 Wochen
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Medical Device Supply Chain Manager
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Device Development Specialist
vor 3 Wochen
Basel, Basel-Stadt, Schweiz Roche VollzeitThe RoleRoche is seeking a highly skilled Device Engineer to join the Device Development Department within Roche Technical Development. The successful candidate will be responsible for the development and support of drug delivery devices for the product portfolio.The Device Engineering group performs combine design, engineering, testing, and manufacturing to...
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Quality Assurance Specialist
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Medical Technology Specialist
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Quality System Specialist
vor 1 Monat
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IT Specialist
vor 1 Monat
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IT Specialist
vor 4 Wochen
Basel, Basel-Stadt, Schweiz CTC Resourcing Solutions VollzeitJob Title: IT Specialist - Medical TechnologyWe are seeking an experienced IT Specialist to join our team in Basel, Switzerland. As an IT Specialist - Medical Technology, you will be responsible for integrating medical devices, ensuring data exchange between medical devices and hospital systems, and providing technical support for server and client-based...
Device Quality Management Systems Support Specialist
vor 2 Monaten
We are seeking a highly skilled and experienced professional to join our team as a Device Quality Management Systems Support Specialist. As a key member of our Global Device Quality organization, you will be responsible for leading and managing the Quality Management Systems (QMS) aspect of medical devices and drug-device combination products across the entire product lifecycle.
Key Responsibilities- Develop, implement, and maintain global standards and SOPs, including the Medical Device Quality Manual, and training materials in collaboration with Pharmaceutical Quality System representatives, Device community, and network stakeholders.
- Ensure that applicable regulatory requirements are incorporated by monitoring and assessing the impact of evolving regulations, guidance documents, health authority expectations, industry trends, and Roche inspection commitments.
- Monitor and assess site implementation activities to ensure the appropriateness of gap assessment/remediation activities and determine if a network approach is warranted.
- Establish a process to communicate relevant changes of our Pharma Quality System to the Notified Body and influence other PQS Squads to ensure devices are incorporated where necessary.
- Develop solutions to improve partnerships and alignment across the network.
- Develop and drive customer-focused, intuitive, balanced, and risk-based decisions and solutions that meet evolving business and regulatory needs.
- Lead or participate on internal cross-functional and self-managed teams using a network mindset and agile approaches to improve processes and standardize best practices by proactively providing direction and guidance to the network on interpretation, understanding, and execution of requirements, and best practices for maintaining a quality program.
- Be deputy of the Management Representative per ISO 13485 and 21 CFR 820 and a.o. responsible for preparation and execution of Management reviews and related strategy and operations.
- Identify and mitigate issues and inspection risks, lead defining strategies.
- A Degree in Engineering or Science discipline with 7-10 years of experience.
- Working experience in medical device quality functions within the combination product area, preferably in a pharmaceutical organizational setting.
- A thorough understanding of the life science industry and specifically of combination products and medical devices.
- Experience with applying a risk-based approach - Risk Management.
- Solid understanding of Quality Management System (QMS), including deviation and CAPA management.
- An in-depth understanding of Design Verification; Design Validation; Design Controls including Process validation/Manufacturing process control.
- Organizational change management, good project management skills, Drug-Device Interactions.
- Understanding of quality requirements for Human Factors related activities.
- Interpretation and application of Regulatory and Internal Requirements.
- Working knowledge of applicable standards and regulations e.g. ISO 13485, 21 CFR 820, EU MDR, and ISO 14971.
- Travel as needed (20-30%).
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity, and diversity.
Roche Pharma Canada has its office in Mississauga, Ontario, and employs over 850 employees. The Mississauga facility is bright, vibrant, fosters collaboration and teamwork, and is reflective of Roche's truly innovative culture.
As of January 4, 2022, Roche requires all new employees who work in Canada to be fully vaccinated against COVID-19 on the date they take office. This requirement is a condition of employment at Roche that applies regardless of whether the position is on a Roche campus or remotely. If you have a valid reason for not being fully immunized, which is limited to certain specific medical reasons or other valid reasons protected by applicable human rights laws, you may request an exemption and/or adaptation measures regarding this vaccination requirement.
Roche is an Equal Opportunity Employer.
