What are the responsibilities and job description for the Quality Assurance & Compliance Specialist- Medical Devices position at AL Solutions?
About the Role:
Mauricio Ducassi is seeking an experienced Quality Assurance Compliance professional for a Medical Devices based client in Riviera Beach, FL. This is a critical onsite role requiring a hands-on leader with deep knowledge of ISO 13485, regulatory compliance, and audit management within a medical device or regulated manufacturing environment.
Responsibilities:
- Lead and manage internal and external quality audits
- Write, review, and maintain compliance documentation (SOPs, CAPAs, protocols, etc.)
- Ensure adherence to ISO 13485 and support compliance with MDD/MDR, CE, and CSA requirements
- Collaborate cross-functionally with manufacturing, regulatory, and leadership teams
- Support and foster a culture of quality and continuous improvement
- Work onsite 40 hours per week at our manufacturing facility
Qualifications:
- Proven experience with ISO 13485 in a medical device or related regulated industry
- Strong knowledge of MDD/MDR, CE marking, and CSA compliance
- Demonstrated ability to lead audit teams and manage audit processes
- Excellent technical writing and documentation skills
- Highly organized, detail-oriented, and proactive
- Strong interpersonal and cross-functional communication skills
About the Company:
Growing company with over 50 years of experience in designing and building high-quality hyperbaric chambers. only company in the industry that offers a full range of both monoplace and multiplace systems. Their products are used in hospitals and wound care clinics around the world. They specialize in the making, setup, and support of hyperbaric oxygen therapy systems, and are known for their strong values and top-tier product quality.
