medmix · 4 days ago
Quality Specialist
Medmix is a global leader in high-precision delivery devices, dedicated to innovation and quality. The Quality Specialist will assist in managing the quality management system, ensuring compliance with regulatory standards, and supporting operations and customer teams.
Health CareManufacturingMedicalMedical Device
Responsibilities
Coordinate information gathering and communication for quality complaint. Support local and global nonconformance investigations of internal and external product complaints
Leads and participates in formal problem-solving, including formal reporting for internal and external customers
Internal auditing of ISO 9001 Quality Management System and serve as Management Representative to the Quality System Registrar
Track key metrics and report on the performance of the QMS (e.g., results of quality audits, corrective actions), including root cause and counter measures
Serves as a quality liaison between supply chain, operations, and design authority when quality problems exist that affect product quality and customers
Work directly with Operations management to establish and monitor quality metrics and ensure the metrics are achieved
Prepare and reports activity updates for management to keep them apprised of quality initiatives and concerns
Tracks local and global KPI’s and reports weekly/monthly as needed
Qualification
Required
3-5 years of experience in a Quality Assurance role focusing on ISO 9001 compliance standards and internal auditing methods
Experience working in a customer-facing environment, preferably in industrial manufacturing
Associate's or Bachelor's degree preferred
Strong computer skills including Microsoft Office, QA applications and databases
Knowledge of tools, concepts, and methodologies of QA
Solid experience in effective usage of data analysis tools and statistical analysis
Knowledge of relevant regulatory requirements, local and state
Preferred
Certifications an advantage including Quality Auditor, Quality Engineer, Quality Improvement Associate, Six Sigma
Quality inspection, auditing and testing experience, ISO 9001, 14001, 45001
Experience with implementation of corrective action programs
Product or industry-specific experience preferred
Benefits
Medical, dental, vision, Life/AD&D, Short- and Long-Term Disability
Employee Savings Plan / 401k with 100% employer match
Company
medmix
Medmix produces and supplies medical equipment, including dental syringes, spreaders, and accessories for the healthcare sector.
Funding
Current Stage
Late StageRecent News
2025-07-24
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