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  • Senior Quality Specialist Belgrade
  • Velsera in Belgrade, , Serbia
  • jobs
  • 1 week ago

jobs description

Welcome to the era of Velsera! Seven Bridges, Pierian & UgenTec have combined to become Velsera.

Velsera is the precision engine company. We empower researchers, scientists, and clinicians to drive precision R&D, expand access to, and more effectively leverage analytics at the point of care.

We unify technology-enabled solutions and scientific expertise to enable a continuous flow of knowledge across the global healthcare ecosystem. This interweaves diverse biomedical communities, allowing them to build upon each other’s success and accelerate medical breakthroughs that positively impact human health.

With our headquarters in Boston, MA, we are growing and expanding our team which located in 14 different countries!

Job Role: Senior Quality Specialist

Location: Belgrade, Serbia

What will you do?
• Manage the Integrated Management System (IMS) document changes and approval workflows.
• Manage and maintain the Velsera document management tool.
• Participate in assigned continuous... improvement initiatives.
• Conduct activities related to internal and external audits as assigned.
• Track non-conformities and CAPAs to closure cross organization.
• Timely monitor and report on KPIs.
• Provide quality related trainings in Velsera.
• You collaborate across teams and make sure quality is part of the daily operations.
• Participate in management review activities as assigned.
• Lead larger QA related projects cross organization.

What do you bring to the table?
• BS Degree in Computer Science, Information Technology or Biomedical Engineering or equivalent
• degree
• Relevant industry experience of 5+ years with demonstrated achievements in the areas of
• responsibilities mentioned above.
• Sound knowledge of Industry standards: ISO 13485, ISO 14971
• Understanding of Regulatory requirements: 21 CFR Part 820 & Part 11, EU MDR or IVDR
• Good understanding of software development methodologies (waterfall, agile etc)
• Fluent in English
• Knowledge & experience of managing compliance using software tools.
• Good understanding of information security domain like ISO 27001 is a plus.
• Trained internal auditor for ISO 9001 and or ISO 13485 is a plus.
• Proven Project Management experience is a plus.

Soft skills:
• Quick learner
• Self-driven & self-organizing
• Precise, accurate and eye for detail
• Proactive, Takes initiative.
• Positive attitude and solution orientation.
• Be able to work independently, with limited supervision.
• Very good oral, written communication, and presentation skills.

Relevant certification by reputed institutes is a plus:
• ASQ: Six Sigma (YB)
• ASQ (CSQA)
• PMI (PMP, ACP)
• Scrum.org (SM)

Our Core Values

People first. We create collaborative and supportive environments by operating with respect and flexibility to promote mental, emotional and physical health. We practice empathy by treating others the way they want to be treated and assuming positive intent. We are proud of our inclusive diverse team and humble ourselves to learn about and build our connection with each other.

Patient focused. We act with swift determination without sacrificing our expectations of quality. We are driven by providing exceptional solutions for our customers to positively impact patient lives. Considering what is at stake, we challenge ourselves to develop the best solution, not just the easy one.

Integrity. We hold ourselves accountable and strive for transparent communication to build trust amongst ourselves and our customers. We take ownership of our results as we know what we do matters and collectively we will change the healthcare industry. We are thoughtful and intentional with every customer interaction understanding the overall impact on human health.

Curious. We ask questions and actively listen in order to learn and continuously improve. We embrace change and the opportunities it presents to make each other better. We strive to be on the cutting edge of science and technology innovation by encouraging creativity.

Impactful. We take our social responsibility with the seriousness it deserves and hold ourselves to a high standard. We improve our sustainability by encouraging discussion and taking action as it relates to our natural, social and economic resource footprint. We are devoted to our humanitarian mission and look for new ways to make the world a better place.

Velsera is an Equal Opportunity Employer:

Velsera is proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, colour, gender, religion, marital status, domestic partner status, age, national origin or ancestry
Belgrade Serbia

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