Quality Control Specialist

Quality Control SpecialistPosition OverviewWe are seeking a detail-oriented Quality Control Specialist to ensure the safety, reliability, and compliance of medical device products. The role will support production and quality systems by performing inspections, testing, and documentation in accordance with FDA regulations, ISO standards, and Good Manufacturing Practices (GMP). The ideal candidate will help maintain product quality, drive continuous improvement, and support audits and corrective actions.Key ResponsibilitiesPerform incoming, in-process, and final inspections and testing of medical devices to verify conformance with specifications and quality standards.Execute and document quality control tests using established procedures, test methods, and measurement equipment.Maintain accurate quality records, generate inspection reports, and ensure traceability of materials and test results.Support internal and external audits, including FDA and ISO-related assessments, and assist with implementing corrective and preventive actions (CAPA).Monitor production processes and collaborate with manufacturing, engineering, and supplier teams to identify and resolve quality issues.Review and help maintain quality documentation including inspection plans, work instructions, SOPs, and nonconformance reports.Calibrate, maintain, and validate QC equipment and test fixtures according to GMP and company procedures.Participate in continuous improvement initiatives, root cause investigations, and risk assessments to reduce defects and improve product reliability.QualificationsBachelors degree in life sciences, engineering, quality assurance, or a related field, or equivalent practical experience.2+ years of experience in quality control within the medical device industry or regulated manufacturing environment preferred.Working knowledge of FDA regulations (21 CFR), ISO 13485, and Good Manufacturing Practices (GMP).Hands-on experience with QC testing methods, inspection tools, and measurement equipment (e.g., calipers, micrometers, gauges).Proven ability to document and report quality issues, write nonconformance reports, and support CAPA processes.Strong attention to detail, analytical and problem-solving skills, and ability to work independently and in cross-functional teams.Familiarity with quality management systems (QMS) and electronic records systems (e.g., ERP, LIMS, or QMS software).Excellent communication skills and the ability to support audits, train staff on quality procedures, and interact with suppliers and regulatory bodies.BenefitsComprehensive health, dental, and vision401KPTO/HolidaysProfessional development opportunities