Quality Engineer

Summary

Join Sword Health, a leading AI-powered healthcare company, as a Quality Engineer (Hardware & Production) and play a crucial role in ensuring the quality and regulatory compliance of our medical device hardware. Based in Porto, Portugal, you will collaborate with cross-functional teams to uphold the highest safety and effectiveness standards. Key responsibilities include defining and maintaining QA strategies, driving design transfer activities, conducting audits, participating in process improvements, ensuring regulatory compliance, managing suppliers, performing root cause analysis, and managing risk. You will also contribute to documentation and reporting. This position requires a Bachelor's degree in a relevant field, 2-4 years of experience in quality assurance or engineering within medical device environments, and a solid understanding of quality system processes and relevant regulations. Sword Health offers a comprehensive benefits package including health insurance, meal allowance, equity shares, remote work allowance, flexible hours, unlimited vacation, and more.

Requirements

• Bachelor's degree in Science, Engineering or related discipline
• 2–4 years of experience in Quality Assurance or Quality Engineering, preferably within medical device hardware development or manufacturing environments
• Solid understanding of core quality system processes, including: Document and Change Control; internal audits; design controls, CAPAs and non-conformities
• Demonstrated experience supporting new product development (NPD) and design transfer
• Working knowledge of relevant medical device regulations and standards, including ISO 13485; 21 CFR Part 820; ISO 14971; ISO 60601
• Experience assisting in the execution of validation activities, such as protocol drafting, execution of IQ/OQ/PQ, data collection, and deviation handling
• Familiarity with risk analysis tools, including FMEA (design/process), hazard analysis, and traceability matrices; ability to contribute to risk file maintenance
• Comfortable using statistical tools for quality and validation (e.g., Excel, Minitab, Gage R&R, control charts); understanding of capability and trending metrics
• Skilled in structured problem solving and root cause analysis techniques (5 Whys, Fishbone, Pareto); experience in documenting and following up on CAPAs
• Fluent in English

Responsibilities

• Define and maintain QA strategies across the product lifecycle, with a focus on hardware development and integration into combination products
• Provide quality support during product development and design changes, ensuring it complies with ISO 13485, FDA 21 CFR 820, IEC 60601
• Drive and support Design Transfer activities, ensuring appropriate controls are in place for scaling, qualification, and validation of equipment and processes
• Ensure proper traceability between design requirements, risk controls, and verification activities through DMR/Device Master Records
• Conduct regular audits of production processes
• Participate in validation lifecycle improvements, identifying process gaps in IQ/OQ/PQ documentation and long-term performance monitoring
• Support and develop process KPIs with R&S process development & improvement and QC/QA teams
• Leverage validation and production data to drive continuous improvement initiatives, using tools such as SPC, DOE, control charts, or capability studies
• Contribute to change control assessments, ensuring that changes to hardware, test methods, or processes are evaluated for revalidation and risk impact
• Translate regulatory requirements into practical, risk-based quality controls across design, validation, and manufacturing processes
• Ensure validation activities are conducted and documented in accordance with regulatory expectations
• Participate in the qualification and monitoring of critical suppliers
• Support or lead supplier audits, and implement quality agreements that define validation responsibilities, traceability, and change notification processes
• Lead investigations into the applicable non-conformities, utilizing tools such as 5 Whys, Fishbone Diagrams, and Failure Modes and Effects Analysis (FMEA)
• Ensure non-conformity outputs are linked back to risk files, validation updates, and Process improvements
• Collaborate with R&S, QARA, ISC and Tech Ops to maintain and update Product, Design and Process FMEAs
• Ensure risk control measures are implemented and verified during validation, and that any residual risks are documented and justified
• Own or contribute to the generation and maintenance of (audit-ready) documentation related to validation, qualification, and test method development
• Track and report quality metrics and KPIs, such as first-pass yield, rework rates, and validation deviations, to Quality leadership

Preferred Qualifications

• Six Sigma or Lean Manufacturing exposure is preferred; certification is a plus but not required. Focus is on practical experience
• Mission-first mindset – Understands that the ultimate goal is to serve patients, not just meet KPIs. Brings purpose to daily execution
• Owner mentality – Takes full responsibility for assigned tasks, follows through independently, and contributes to team success
• Delivers more than expected – Goes beyond the minimum: prepares well, double- checks work, and delivers with accuracy under time pressure
• Learns fast and adapts faster – Sees mistakes as opportunities to grow, asks for feedback, and adjusts quickly in a very fast-paced environment
• Thrives in a high-performance environment – Knows how to manage shifting priorities, remains calm under pressure, and still uphold quality standards
• Resourceful and efficient – Makes smart use of tools, templates, and support systems. Suggests better ways to work without being wasteful
• Collaborative communicator – Brings clarity and accountability in conversations with engineers, operations, suppliers, and QA leadership

Benefits

• Health, dental and vision insurance
• Meal allowance
• Equity shares
• Remote work allowance
• Flexible working hours
• Work from home
• Unlimited vacation
• Snacks and beverages
• English class