Suna Solutions · 20 hours ago
Senior Quality Engineer (Electro-mechanical)
San Diego, CA
Full-time
Onsite
Senior Level, Lead/Staff
$130K/yr - $150K/yr
8+ years expSuna Solutions is an innovative medical device company seeking a Senior Quality Engineer (Electro-mechanical). This role is responsible for implementing and optimizing quality processes within the Quality Management System for Class II medical devices, ensuring compliance with regulatory standards and leading continuous improvement initiatives.
DeliveryHuman ResourcesInformation Technology
Responsibilities
Implement and maintain QMS processes in compliance with 21 CFR Part 820, ISO 13485:2016, and ISO 14971, including design controls, document control, change control, CAPA, non-conformance investigations, and supplier quality management
Lead product and process validation activities, including IQ/OQ/PQ, test method validation, and statistical analysis using tools like Minitab or DOE
Conduct risk assessments (e.g., FMEA, hazard analysis) and support post-market surveillance, complaints handling, and vigilance reporting
Perform internal and supplier audits, prepare for FDA inspections and third-party audits (e.g., MDSAP, Notified Body), and drive corrective actions
Facilitate root cause analysis (RCA) using techniques like 5-Why, fishbone, and 8D to resolve quality issues and improve process effectiveness
Review and approve design verification/validation protocols, manufacturing documentation, and change orders for regulatory compliance
Develop and track quality metrics, KPIs, and objectives to support Management Review Meetings and continuous improvement
Ensure audit readiness of technical files, Device Master Records (DMR), and Device History Records (DHR)
Partner with R&D, quality, process engineering and manufacturing teams to integrate quality requirements into product design and process development
Provide quality oversight for any special processes related to electromechanical product SKUs, product release of the same, and labeling compliance (e.g., UDI, IFU) of the same
Support regulatory submissions by contributing to risk management files and technical documentation for 510(k) or de novo pathways
Mentor junior staff and at supplier sites on quality tools and best practices, fostering a culture of quality in a startup environment
Qualification
Required
Bachelor's degree in mechanical, electrical, or software engineering, or related field
8+ years in medical device quality engineering
3+ years in a senior or lead role supporting Class II/III products or equivalent experience in automotive/aerospace
Proven track record in CAPA systems, design controls, and post-market surveillance for combination products
Experience leading validations and statistical analysis in regulated environments
Strong skills in root cause investigation, data analysis, and risk mitigation under tight deadlines
Excellent oral, written, and presentation skills to interface with cross-functional teams, auditors, and leadership
Ability to guide teams on quality standards, drive continuous improvement, and handle escalated issues
Manage DMR deliverables, assigned program checklists, validation timelines, audits, and CAPAs using agile methodologies in resource-constrained settings
Thrive in dynamic startup environments with evolving priorities and regulatory changes
Preferred
Master's degree or ASQ Certified Quality Engineer (CQE) certification strongly preferred
Preferred hands-on experience with governmental inspections (i.e. FDA) inspections, ISO 13485 certification, and MDSAP audits
Background in drug-device combinations, electromechanical devices, or wound care technologies preferred
Preferred deep knowledge of 21 CFR 820, ISO 13485, ISO 14971, IEC, 62304 (SDLC), IEC 62366 (usability), and FDA guidance relevant to the SKU type; proficient in quality tools (e.g., FMEA, SPC, RCA) and software (e.g., Minitab, Arena PLM, MasterControl). Must also be proficient in mechanical and electrical design, and have some experience in software-driven control systems
Benefits
Dental insurance
Flexible schedule
Health insurance
Paid time off
Vision insurance
Company
Suna Solutions
Suna Solutions is a staffing and recruiting company offering temporary staffing services.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase