ARC Quality Assurance Director

The ideal candidate will have 4-5 years of experience in the medical devices industry, managing quality processes in development/production and others.

Managed 1-4 team members. Critical thinker who will proactively improve the quality systems of the company through internal audits, participation in process improvement programs, and interaction with key partners to obtain constructive feedback.

Requirements:

Bachelor's degree or equivalent experience in Engineering
5+ years' relevant work experience
Highly organized with excellent attention to detail

Responsibilities:

Providing management and control of the quality assurance processes
Experience in team management
Initiate, monitor, and verify the effective implementation of the Quality Management System (QMS) in all areas of company activities.
Identify potential risks before they become a problem, focusing on root cause analysis and preventive action.
Vast knowledge in ISO13485/21CFR, MDR
Managed and led external audits and worked with notified bodies.
Manage and perform internal and external quality audits and inspections and compile detailed reports of findings.
Manage the quality aspects of the manufacturing and clinical processes including feedback, complaints, and technology malfunctions and failures.
Manage suppliers' evaluation and approval.
Ensuring all processes are controlled and monitored.
Documenting new and existing processes
Training and mentoring company employees and sub-contractors on the quality management system
Maintains the quality infrastructure of the company.

Skills:

Fluently verbal and written English
High ability to work independently.
Self-motivated and proactive
Planning, organizational, and administrative abilities
Good interpersonal skills