Quality Assurance Specialist

Get AI-powered advice on this job and more exclusive features. Direct message the job poster from AL Solutions Connecting CDMO & BioPharma 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 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 Referrals increase your chances of interviewing at AL Solutions by 2x Sign in to set job alerts for “Quality Assurance Specialist” roles. We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr