Were seeking a Senior Quality Specialist to join our companys QA team. In this role, youll lead the implementation and continuous improvement of quality assurance processes – including design controls, change control, and risk management, ensuring our products meet the highest global regulatory and industry standards. Your expertise will directly impact the safety, quality, and compliance of cutting-edge AI healthcare solutions.
What Youll Do:
Lead product release processes for new medical devices and software versions, collaborating closely with R&D, Product, Delivery, and SW QA teams.
Create, Maintain and review product related documentation (DHF, DMR, DHR, TFs) with a deep understanding of product design, implementation, and testing.
Translate regulatory requirements into actionable processes, enhancing efficiency, compliance, and product quality across the organization.
Support core QMS processes including SW Development Life Cycle (SDLC), Risk Management, CAPA, Non-Conformance, Usability, Document Control, Training, and more.
Leading AI and SW quality related problem solving
Cross-functional Collaboration: Work closely with SW engineers, data scientists, and product teams to identify testing requirements, troubleshoot issues, and improve overall AI system quality.
Assist in internal and external audits, ensuring readiness and full compliance.
What Youll Do:
Lead product release processes for new medical devices and software versions, collaborating closely with R&D, Product, Delivery, and SW QA teams.
Create, Maintain and review product related documentation (DHF, DMR, DHR, TFs) with a deep understanding of product design, implementation, and testing.
Translate regulatory requirements into actionable processes, enhancing efficiency, compliance, and product quality across the organization.
Support core QMS processes including SW Development Life Cycle (SDLC), Risk Management, CAPA, Non-Conformance, Usability, Document Control, Training, and more.
Leading AI and SW quality related problem solving
Cross-functional Collaboration: Work closely with SW engineers, data scientists, and product teams to identify testing requirements, troubleshoot issues, and improve overall AI system quality.
Assist in internal and external audits, ensuring readiness and full compliance.
Requirements:
Education & Experience
Bachelors degree in Engineering, Life/Exact Sciences, Quality Assurance or Law.
3+ years in the medical device industry, proven experience in QMS processes with a strong focus on SaMD (software as Medical Device).
Strong knowledge of FDA requirements, MDR regulation, ISO 13485, ISO 62304, ISO 14971 and IEC 62366.
Skilled in product risk assessment, requirements management and tracking, defect tracking, configuration management and how they are applied in the product development lifecycle
Experience improving processes, efficiency, and workflows.
Interest or background in computer science or AI – a plus.
Skills & Qualities
Exceptional project and program management skills.
Structured thinker with the ability to drive cross-functional projects to completion.
Ability to work independently with minimal supervision
Detail-oriented, proactive, and accountable.
Strong communication skills in English, both written and verbal.
Collaborative, team-oriented mindset with a passion for learning and growth.
Education & Experience
Bachelors degree in Engineering, Life/Exact Sciences, Quality Assurance or Law.
3+ years in the medical device industry, proven experience in QMS processes with a strong focus on SaMD (software as Medical Device).
Strong knowledge of FDA requirements, MDR regulation, ISO 13485, ISO 62304, ISO 14971 and IEC 62366.
Skilled in product risk assessment, requirements management and tracking, defect tracking, configuration management and how they are applied in the product development lifecycle
Experience improving processes, efficiency, and workflows.
Interest or background in computer science or AI – a plus.
Skills & Qualities
Exceptional project and program management skills.
Structured thinker with the ability to drive cross-functional projects to completion.
Ability to work independently with minimal supervision
Detail-oriented, proactive, and accountable.
Strong communication skills in English, both written and verbal.
Collaborative, team-oriented mindset with a passion for learning and growth.
This position is open to all candidates.
