Quality Technician - III

Quality Technician - III Prevailing Medical Minneapolis, MN Job Details Full-time $60,000 - $80,000 a year 1 day ago Qualifications Quality control corrective actions Regulatory inspections Microsoft Excel ISO standards Regulatory compliance Compliance audits & assessments Corrective and preventive actions (CAPA) Quality management Quality inspection FMEA Productivity software Quality audits Quality systems Root cause analysis FDA regulations Engineering validation

Full Job Description Job Title:

Quality Tech III Company:

Prevailing Medical Job Type:

Full-Time About Prevailing Medical Prevailing Medical is a contract medical device manufacturer focused on delivering high-quality, innovative solutions to our partners. We specialize in supporting development through production with a strong emphasis on precision, compliance, and customer success. Position Overview We are seeking an experienced and detail-oriented Quality Technician to join our team. This role is ideal for someone who can take ownership of quality processes, drive improvements, and work cross-functionally to ensure compliance and product excellence within the medical device industry. Key Responsibilities Maintain and improve the Quality Management System (QMS) Lead and support internal and external audits (FDA, ISO, customer) Drive nonconformance investigations and corrective/preventive actions (CAPA) Review and approve manufacturing documentation, including DHRs and work instructions Partner with engineering and production teams to resolve quality issues and implement process improvements Support validation activities (IQ/OQ/PQ) and risk management processes Analyze quality data and metrics to identify trends and drive continuous improvement Ensure compliance with FDA regulations and

ISO 13485

standards Management Representative Qualifications Minimum 8-10 years of experience in Quality within the medical device or regulated industry Strong understanding of QMS, CAPA, and root cause analysis Experience with audits and regulatory inspections Excellent problem-solving, communication, and organizational skills Proficiency in Microsoft Office (Excel, Word) Experience with ISO 13485 and

FDA 21 CFR

Part 820 Familiarity with validation and risk management (FMEA) Preferred (but not required) Experience in contract manufacturing environments Why Join Prevailing Medical? Opportunity to take ownership of quality systems and processes Career growth in a fast-paced, growing company Collaborative, hands-on environment Exposure to innovative medical device technologies

Pay:

$60,000.00 - $80,000.00 per year

Work Location:

In person