SUMMARY:

RTT Medical is a medical device company in the field of regenerative medicine. Headquartered in Orlando, Florida, RTT Medical is passionate about helping to restore function and quality of life to patients with advanced wounds. We are hiring individuals who have an interest in advancement within a small rapidly-growing company. We offer a comprehensive benefits package which includes health, dental and 401(k). The Quality Engineer is assigned to domestic (U.S.) projects maintaining, monitoring, and improving the quality management system; and works closely with RA, Product Development and Manufacturing/Operations.

ESSENTIAL FUNCTIONS:

1. Support development of the Quality Assurance Department.
2. Establish quality inspections, criteria, tooling, equipment and test methods for raw materials, materials in process and finished products.
3. Knowledge of statistical techniques, development of rationale for validation sample size.
4. Lead the supplier audit and qualification process, managing the Approved Supplier List.
5. Domestic travel will be expected to perform critical supplier audits.
6. Lead internal (CAPA) and supplier corrective action requests.
7. Lead internal and external investigations (identifying root causes) of nonconformities, corrective actions, complaints, HHEs.
8. Identify and lead projects to drive reductions in failure rates and the cost of poor quality.
9. Lead management reviews as the Management Representative.
10. Support of Product Development verification protocols and reports, and Manufacturing process validation protocols and reports.
11. Support risk management activities within the design controls process and quality system.
12. Work with internal stakeholders to ensure effective problem-solving and resolution planning.
13. Transform data findings into recommendations to compose reports and executive-level presentations.
14. Create and improve processes using pFMEA, process control plans, work instructions and operator training.
15. Knowledge of post-market surveillance and medical device reporting.
16. Provide post-market input and feedback on safety for quality reports, design reviews, risk analysis.
17. Support Document Change Requests and Engineering Change Notifications.
18. Lead internal and external (FDA) quality audits.
19. Other typical QE tasks as assigned based on project needs.

EDUCATION AND EXPERIENCE:

1. Bachelor or master’s degree in biomedical engineering, quality engineering, science, or related field.
2. Certified Quality Engineer (ASQ CQE) a plus, but not required.
3. Minimum 5 years of experience in quality systems, quality assurance, risk management and/or quality engineering.
4. Experience working in medical device industry.

KNOWLEDGE, SKILLS & ABILITITES:

1. Working knowledge of US 21 CFR 820, ISO 13485, MDSAP, ISO 14971.
2. Proficiency in medical device design controls process.
3. Strong analytical and problem-solving skills.
4. Excellent organizational skills.
5. Ability to work independently and collaboratively with different people across the organization.
6. Excellent verbal and written communication skills
7. Proficient with various computer programs including Microsoft Office 365.
8. Love of learning and positive attitude.
9. Trustworthy.

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 essential functions:

1. Sitting, standing, and/or walking for up to eight hours per day.
2. Routine use of standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machine.