Senior Quality System Engineer

Summary

Join Sword Health, a healthcare company using AI care programs to alleviate physical pain, as a Senior Quality System Engineer (Hardware & Production). You will ensure quality and regulatory compliance of hardware components in medical devices and production lines. Collaborate with cross-functional teams to maintain safety and effectiveness standards. The ideal candidate is detail-oriented and located in the Salt Lake City area. This role involves defining QA strategies, supporting product development, conducting audits, improving processes, ensuring regulatory compliance, managing suppliers, performing root cause analysis, managing risk, and generating documentation. Sword Health offers a mission-driven environment and numerous benefits.

Requirements

• Bachelor's degree in Science, Engineering or related discipline
• 4–6 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

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

• Comprehensive health, dental and vision insurance*
• Life and AD&D Insurance*
• Financial advisory services*
• Supplemental Insurance Benefits (Accident, Hospital and Critical Illness)*
• Health Savings Account*
• Equity shares*
• Discretionary PTO plan*
• Parental leave*
• 401(k)
• Flexible working hours
• Remote-first company
• Paid company holidays
• Free digital therapist for you and your family