Design, develop, and maintain FDA and ISO 13485 compliant quality system(s) that support the design, manufacturing, service and support all medical devices and services provided by company.

Responsibilities and Duties:
• Responsible for creating and maintaining a quality system that are compliant to FDA GMP regulations 21 CFR 820, etc.
• Responsible for creating and maintain a quality system that is compliant to ISO 13485, 2016 quality system standards.
• Responsible for company’s QT9 Quality Management system.
• Quality System Elements include, but not limited to the following:
a) Audits, external – FDA, notified body, others
b) Audits, internal
c) Calibration program
d) Corrective Action
e) Customer Complaint handling review and reporting
f) Customer feedback systems
g) Document Control Admin, Change Control Board
h) Inspection Programs
a. Final inspection
b. Incoming inspection
c. Inprocess inspection.
d. Creation of inspection plans
i) Maintenance program, using QT9 QMS
j) Management Representative
k) Management Review Meetings – twice per year
l) Material Review Board member
m) MDR handling and reporting
n) Nonconformity Products
o) Preventative Action
p) Quality Manual, quality policy, quality objectives
q) Quality Records
r) Quality system training, Admin
s) Quality trending and reporting
t) Recall coordination, as required.
u) Risk assessment and reporting
v) Supplier qualification and audit

• Prepares reports by collecting, analyzing, and summarizing information and trends.
• Maintains product and company reputation by complying with government regulations and international standards.
• Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.
• Contributes to team effort by accomplishing related results as needed.

Skills/Qualifications:
• Excellent communication skills, written and verbal.
• Experience in Medical Device industry and quality system development and maintenance.
• Bachelor's degree required.
• Quality Focus
• Fluent in English