Quality Assurance Specialist

AL Solutions; Riviera Beach (FL); On-site; USD 80,000 - 95,000; Full time

Job summary

A leading company in medical device manufacturing is seeking a Quality Assurance Compliance Specialist in Riviera Beach, Florida. The ideal candidate will thrive in regulated environments, lead audits, and contribute to continuous quality improvement. This full-time role offers a competitive salary and the chance to work with high-specification Class II medical devices.

Qualifications

• Strong experience with ISO 13485 quality systems.
• Proven experience leading audit teams.

Responsibilities

• Lead and coordinate internal and external audit teams.
• Develop and maintain quality and compliance documentation.
• Ensure compliance with ISO 13485 and MDD/MDR standards.

Skills

ISO 13485

Documentation

Communication

Job description

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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
• Most have in-depth knowledge of MDD/MDR 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

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Biotechnology Research, Medical Equipment Manufacturing, and Pharmaceutical Manufacturing

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