Quality Assurance Engineer I – Medical Devices

About the role

Confluent Medical Technologies seeks a Quality Assurance Engineer I to support internal audits, external inspections, and quality system performance across its medical device manufacturing sites. The role involves data collection, analysis, and documentation to ensure compliance with ISO and other regulatory standards.

Key responsibilities

• Participate in internal audits and assist with customer inspections, including planning, evidence collection, and report preparation.
• Track, review, and close corrective actions and CAPA items under guidance.
• Collect, verify, and analyze Quality System data for the local site and other company locations.
• Prepare and present data for Management Review and other quality performance meetings.
• Identify improvement opportunities from performance information and support implementation.
• Maintain external standards documentation and manage related controlled documents.
• Escalate significant compliance concerns, gaps, or risks to senior management.
• Support activities related to Training Management, Complaint Management, and External Standards Management.

Required profile

• Bachelor’s degree in Engineering or a related discipline (completed).
• Minimum of 6 months of relevant professional experience.
• Availability to work a standard M‑F shift (8 am – 5 pm).

Required skills

• Knowledge of Quality Management Systems (QMS) and ISO standards.
• Experience with CAPA processes.
• Familiarity with audit documentation and corrective action tracking.

What we offer

• Opportunity to work on cutting‑edge medical device projects.
• Collaboration with multidisciplinary teams in a fast‑growing company.
• Professional development in a regulated manufacturing environment.