Company Description

ZetrOZ Systems is a healthcare technology company based in Trumbull, CT, specializing in soft tissue healing therapeutics. The company's innovations are designed for acute and chronic musculoskeletal conditions to enhance tissue recovery, accelerate natural healing processes, and relieve pain. ZetrOZ Systems serves millions of patients globally with proprietary medical technology platforms.

Role Description

This is a full-time on-site role for a Quality Specialist at ZetrOZ Systems in Trumbull, CT. The Quality Specialist will be responsible for tasks related to quality control, auditing, assurance, and communication. The day-to-day responsibilities include ensuring quality standards are met, conducting audits, maintaining documentation, and communicating quality issues effectively.

Responsibilities

• This position is primarily focused on maintaining and improving quality processes and leading inspection of manufacturing ultrasound systems and accessories
• Process Validation: IQ/OQ/PQ and developing protocols for new product manufacturing validation
• Supplier Quality: Manage supplier changes and work with Operations/Engineering to evaluate change impact to product performance. Improve supplier scorecard and track performance (e.g. risk management related to supplier/supply chain, site inspections, assessments
• Quality Control: Develop and implement quality control plans for single use products and electronic ultrasound systems and utilize statistical techniques to analyze and improve manufacturing output.
• Develop and maintain inspection and quality control procedures
• Corrective Action: Manage CAPA initiatives to drive continuous improvement.
• Project Leadership: Manage improvements across multiple product lines
• Technical Documentation: Maintenance of records for compliance with FDA regulation and ISO 13485 standard

Qualifications

• Minimum of 4 years experience in medical device manufacturing
• Experience with intake inspection
• Knowledge of FDA regulations and ISO 13485 requirements
• Proficiency in statistical analysis methods
• Knowledge of medical device validation requirements
• Proficiency in reviewing engineering drawing and design changes for risk analysis and impact on product 
• Bachelor's degree in a related field

Compensation

• Competitive full-time salary based on CT-Pay bands
• 401(k) and Profit Share
• Health Insurance
• Paid Vacation
• Quarterly Performance Bonus