Quality Assurance Specialist
Listed on 2026-02-06
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Quality Assurance - QA/QC
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Healthcare
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Connecting CDMO & Bio Pharma Talent across the US.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
Mid-Senior level
- Employment type
Full-time
- Job function
Quality Assurance - Industries Biotechnology Research, Medical Equipment Manufacturing, and Pharmaceutical Manufacturing
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