REVIAN · 20 hours ago
Senior Quality Engineer
Morrisville, NC
Full-time
Onsite
Senior Level
5+ years expREVIAN Inc is a medical technology innovator dedicated to rejuvenating hair and skin with light. They are seeking a Senior Quality Engineer to manage, investigate, and document product complaints, ensuring compliance with US FDA and ISO 13485 requirements.
Health CareManufacturingMedical
No H1B
Hiring Manager
Darlene Dendy
Responsibilities
Manage, investigate, and document product complaints to ensure complaints are closed within designated time periods
Assist R&D and Quality in Change Management
Perform duties and other analyses as requested by members of management
Assist in corrections to the Quality System including investigations and closure of Corrective and Preventive Actions
Adhere to and ensure compliance with Revian’s quality system
Qualification
Required
BSc, MSc, or PhD in an engineering or physical science field. Electrical Engineering preferred
5+ years of experience in the medical device industry and within a Quality System compliant with 21 CFR 820 or ISO 13485
5+ years of experience in medical device Complaint/Returned Goods Investigations and Failure Analysis
Experience in troubleshooting electrical, mechanical, and software functions required
Ability to summarize test methods and results as well as draw conclusions required
Ability to evaluate and summarize data trends and perform statistical analyses required
Prioritize and manage multiple projects in a fast-paced environment with minimal supervision while maintaining strong attention to detail
Self-starting and self-motivating team player with the ability to work autonomously
Willingness to quickly adapt to changing priorities and manage multiple tasks
Strong interpersonal skills, effective written and verbal communication, problem solving, and decision-making skills
Preferred
Experience with measurement methods and measurement equipment such as but not limited to multimeters and oscilloscope
Experience with troubleshooting hardware and embedded firmware
Prior experience with FMEA and root cause analysis
Knowledge and experience with LED technology including LED bands and characteristics, lenses, and optics
Proficiency with MiniTab, JMP, R or other statistical computing software
Detailed knowledge of Microsoft Project, Smartsheet, or other project management software
Company
REVIAN
Revian is the manufacturer and supplier of medical-grade LED technology.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
$13MKey Investors
Flashpoint
2025-11-20Series Unknown· $13M
2025-11-20Debt Financing
Leadership Team
Amy Miller Keish
Vice President of Healthcare Sales
Recent News
2025-11-25
Company data provided by crunchbase