Quality Assurance Specialist

Conduct calibration monitoring on calibrated equipment Maintain and support the company's quality management system in accordance with ISO 13485, FDA QSR (21 CFR Part 820), and other applicable regulatory requirements Create, revise, and maintain quality documentation, including work instructions, inspection checklists, SOPs, and inspection records Support internal and external audits by preparing documentation and evidence of compliance Assist with supplier and vendor quality evaluations as needed Initiate and track non-conformance reports and coordinate root cause analysis with relevant departments Support the corrective and preventive action process, tracking action items through to closure Escalate recurring or high-risk quality issues to the Quality Manager and relevant department leads Track and report quality metrics, including defect rates, inspection results, and CAPA status, to management Recommend process improvements to reduce defects, rework, and returns Participate in cross-functional meetings with Operations, Technical Support, and Sales to communicate quality trends and risks Perform other duties as assigned based on business needs Requirements High school diploma or GED required 2–3+ years of experience in quality assurance, quality control, or inspection, ideally within medical devices, electronics, or a regulated manufacturing environment Working knowledge of quality management systems and inspection documentation practices Ability to read and interpret technical specifications, schematics, and work instructions Strong attention to detail and accurate record-keeping skills Effective written and verbal communication skills for documenting findings and collaborating across teams Must be able to travel 10%-15% (at least once per quarter) Experience with ISO 13485 or FDA 21 CFR Part 820 quality systems preferred ASQ certification (CQA, CQT, or CQI) or equivalent preferred Experience with medical device refurbishment, biomedical equipment, or healthcare technology preferred Familiarity with CAPA and non-conformance preferred Experience with EQMS preferred Core Competencies Demonstrates expertise in quality management systems, particularly ISO 13485 and FDA QSR compliance, with a strong focus on documentation practices and quality metrics tracking. Capable of conducting audits, managing non-conformance reports, and collaborating across departments to enhance quality processes. Highest-signal resume keywords ISO 13485 Compliance Quality Management Systems Non-Conformance Reporting CAPA Process Management ASQ Certification ATS Optimization Keywords Hard Skills Quality Assurance Quality Control Inspection Documentation Root Cause Analysis Defect Rate Tracking Technical Specification Interpretation SOP Creation Quality Metrics Reporting Regulatory Compliance Medical Device Quality Standards Soft Skills Attention to Detail Effective Communication Collaboration Problem-Solving Record-Keeping Certifications & Qualifications ASQ CQA ASQ CQT ASQ CQI Industry Keywords Medical Devices Regulated Manufacturing Biomedical Equipment Healthcare Technology Electronics Tools & Technologies EQMS Inspection Checklists Work Instructions Quality Documentation #J-18808-Ljbffr