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!
As a Senior Quality Specialist, you will report to the Director of Quality. You will communicate assertively & effectively with the product development team and independently carry out the work in accordance with professional standards, step up from daily routine and explore ideas for future and recognize potential challenge and share suggestions as well as set high quality standards for driving overall improvement and success of the team.
What will you do?
- Support implementation of Integrated Management Systems SOPs
- Support all phases of the product life cycle (including, but not limited to requirements development/review/approval, test planning, test execution, and test reporting and assessment)
- Support compliance assessments to ensure quality and regulatory requirements are successfully implemented and maintained
- 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
- Collaborate across teams to deliver the responsibilities
What do you bring to the table?
- BS Degree in Computer Science, Information Technology or Biomedical Engineering or equivalent degree
- 5+ years of relevant industry experience with demonstrated achievements in the areas of responsibilities mentioned above.
- Sound knowledge of Industry standards: (e.g., ISO 13485,) and good understanding of Regulatory requirements: 21 CFR Part 820 & Part 11, EU MDR or IVDR, Annex 11
- Good understanding of agile software development support ways of implementing agile principles in a regulated environment.
- Fluency in English
- Knowledge & experience of managing compliance using software tools
- Quick learner, self-driven & self-organizing and able to work independently
- Proactive and with ability to take initiative
- Precise, accurate, with an eye on details and can to attitude
- Very good oral, written communication, and presentation skills
- Good understanding of information security domain (ISO 27001) is a plus
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.
