Quality Lead (MedTech)

TL;DR

Quality Lead (MedTech): Designing and implementing quality frameworks for clinical digital health devices with an accent on balancing regulatory requirements and innovation velocity. Focus on establishing risk-based quality strategies, translating technical requirements, and guiding cross-functional agile teams through the device development lifecycle.

Location: Remote

Company

hirify.global is an independent technology consulting firm providing expert guidance and solutions across 60 countries in sectors including Life Sciences, Digital, and Engineering.

What you will do

• Design and implement quality processes specifically tailored for digital health devices and software
• Develop and execute risk-based quality strategies prioritizing patient safety and regulatory compliance
• Translate complex technical and regulatory requirements into clear action plans for cross-functional teams
• Oversee device lifecycle quality from initial concept through to clinical deployment
• Lead quality decision-making processes within small, agile project teams
• Identify quality risks and propose innovative, pragmatic solutions

Requirements

• Degree in biomedical engineering, software engineering, or life sciences
• 3-5 years of experience in quality assurance within medical technology or digital health
• Strong understanding of software development lifecycle and digital device technologies
• English: Fluent proficiency required
• Ability to thrive in fast-changing, lean team structures
• Pragmatic mindset with structured problem-solving skills

Culture & Benefits

• Focus on cutting-edge digital health technology projects
• Agile, bureaucracy-light organizational structure
• International environment with opportunities for professional growth across various sectors
• Commitment to diversity, equity, and inclusion

Hiring process

• Initial brief call to discuss motivations and fit
• Approximately 3 interviews with team members and management
• Potential case study, role play, or technical assessment