Senior Quality Engineer

REVIAN Inc, an operating subsidiary of KNOW Bio, LLC, is a medical technology innovator dedicated to stimulating the body’s natural processes to rejuvenate hair and skin with light. We create products that precisely deliver light and allow people to experience its regenerative potential in the convenience of their own home.

We are searching for a self-motivated Senior Quality Engineer (Contract, Full Time) to join our Quality team. The primary focus of this position will be management, investigation, and documentation of returned goods. The candidate must have hands on, bench level experience in failure analysis and functional product testing, The work will be performed on site in Morrisville, NC.

The incumbent engineer will play a pivotal role in ensuring the Quality Management System meets US FDA and ISO 13485 requirements.

Applicants must be authorized to work for any employer in the United States. We are unable to sponsor or assume responsibility for on-going sponsorship of an employment Visa at this time.

Position Title: Senior Quality Engineer (Contract, Onsite)

Reports To: Engineering/Quality Assurance

• 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

Required Skills & Qualifications:

• 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.

Desired Skills and Qualifications:

• 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 Mini Tab, JMP, R or other statistical computing software.
• Detailed knowledge of Microsoft Project, Smartsheet, or other project management software.

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the principal duties and responsibilities.

Typical office environment requirements include reading, speaking, hearing, close vision, walking, bending, sitting, use hands and fingers (i.e. typing), and occasional lifting up to 20 pounds. There will be an occasional requirement to work outside of normal business hours, consistent with other Manager-level positions. Some travel may be required (5-10%).

KNOW Bio maintains a drug-free workplace and performs pre-employment and employment substance abuse testing and background verification checks.

KNOW Bio is an equal opportunity employer and does not discriminate against any employee or applicant for employment. We encourage and foster diversity in the workplace.