Quality Engineering Lead - Regulated Medical Software

Nordic Investin Group Aktiebolag; Stockholms kommun; On-site; SEK 900,000 - 1,200,000; Full time

Job summary

Nordic Investin is seeking a Quality Engineering Lead for Medical Software to drive risk-based quality engineering in a regulated digital health context. You will align quality strategy with IEC 62304, advance test automation, and ensure traceability and supplier quality across delivery teams.

The role emphasizes independent judgment, actionable trade-offs, and applying evidence-based approaches to improve product quality and operability, within a multidisciplinary delivery setup.

Qualifications

• Experience delivering risk-based quality engineering for regulated digital health products.
• Strong knowledge of quality strategy and IEC 62304.
• Practical experience applying test automation and traceability.
• Ability to assess risk, priorities and trade-offs involving supplier quality.
• Evidence of clear stakeholder communication and dependable end-to-end ownership.
• Professional English; Swedish language skills helpful.

Responsibilities

• Own the practical direction for risk-based quality engineering for regulated digital health products.
• Translate goals and constraints into a clear approach for quality strategy and IEC 62304.
• Establish useful standards, routines or artefacts around test automation.
• Coordinate stakeholders and dependencies affecting traceability.
• Use evidence and measurable outcomes to improve supplier quality.
• Strengthen knowledge sharing, decision quality and sustainable ownership across the team.

Skills

Quality leadership

IEC 62304

Test automation

Traceability

Supplier quality

English proficiency

Job description

Nordic Investin is seeking a Quality Engineering Lead for Medical Software to drive risk-based quality engineering in a regulated digital health context. You will align quality strategy with IEC 62304, advance test automation, and ensure traceability and supplier quality across delivery teams.

The role emphasizes independent judgment, actionable trade-offs, and applying evidence-based approaches to improve product quality and operability, within a multidisciplinary delivery setup.