Senior Software Quality Assurance Specialist supporting implementation of management systems at Velsera. Collaborating across teams in the product life cycle within a hybrid work environment.
Responsibilities
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
Requirements
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
Benefits
Flexible Work & Time Off - Embrace hybrid work models and enjoy the freedom of unlimited paid time off to support work-life balance.
Health & Well-being - Access comprehensive group medical and life insurance coverage, along with a 24/7 Employee Assistance Program (EAP) for mental health and wellness support.
Growth & Learning - Fuel your professional journey with continuous learning and development programs designed to help you upskill and grow.
Recognition & Rewards - Get recognized for your contributions through structured reward programs and campaigns.
Engaging & Fun Work Culture - Experience a vibrant workplace with team events, celebrations, and engaging activities that make every workday enjoyable.
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