Job Description

Quality Assurance Compliance Specialist – Medical Devices

Location: Onsite in Riviera Beach, Florida

Salary: Up to $95,000 per year

Employment Type: Full-time, 40 hours per week

We are supporting a U.S.-based medical device manufacturer that designs and builds high-specification Class II medical devices within Respiratory for hospital and clinical environments. Known for engineering excellence and a strong commitment to regulatory compliance, the company has a long-standing reputation for delivering safe, effective, and durable systems that support patient care in critical settings.

As part of their ongoing growth, the company is seeking a Quality Assurance Compliance Specialist to join their onsite team in Riviera Beach, Florida. This role is ideal for someone who thrives in a regulated manufacturing environment and has the confidence to lead audits, maintain compliance systems, and contribute to continuous quality improvement.

Key Responsibilities:

• Lead and coordinate internal and external audit teams
• Develop, review, and maintain quality and compliance documentation
• Ensure ongoing compliance with ISO 13485, MDD/MDR, CE marking, and CSA standards
• Work closely with engineering, manufacturing, and leadership to support quality and regulatory goals
• Identify and implement opportunities for continuous improvement within the quality system

Requirements:

• Strong experience working with ISO 13485 quality systems
• In-depth knowledge of MDD/MDR, CE/CSA standards
• Proven experience leading audit teams and managing audit activities
• Excellent documentation and communication skills
• Must be able to work onsite 40 hours per week in Riviera Beach, FL

Nice to Have:

• Experience in a regulated manufacturing setting, ideally within medical devices
• Familiarity with FDA regulations and other international standards

This is an exciting opportunity to join a company that manufactures life-enhancing technology and takes pride in producing high-performance, compliant medical systems that make a difference in patient care.

If you’re ready for a role where your expertise will be valued and your contributions will have real impact, we’d love to hear from you.

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