ISO Quality Engineer - Lead Auditor

ISO Quality Engineer and Lead Auditor

About Haag-Streit USA

Haag-Streit USA is a global leader in ophthalmic diagnostics and medical technology, dedicated to improving patient care through precision instruments and innovative solutions. Our team works at the intersection of engineering, manufacturing, and regulatory excellence to deliver high-quality medical devices used by clinicians worldwide.

We are seeking a Quality Engineer to support regulatory compliance and quality engineering initiatives across our product portfolio and manufacturing operations.

Position Summary

The Regulatory & Quality Engineer supports both regulatory compliance and quality engineering activities to ensure products, processes, and documentation meet applicable regulatory and quality system requirements.

This role partners closely with cross-functional teams including Manufacturing, Engineering, Product Development, and Purchasing to maintain compliance with FDA 21 CFR 820, ISO 13485, ISO 14971, and other global regulatory standards.

Responsibilities include maintaining regulatory documentation, supporting regulatory submissions, managing change control activities, participating in risk management processes, leading root cause investigations, driving CAPA initiatives, and supporting internal and external audits.

This role also contributes to compliance activities related to IEC 60601 series standards for medical electrical equipment, including electrical safety, EMC, and essential performance requirements.

The ideal candidate has strong analytical skills, attention to detail, and the ability to interpret and apply regulatory and quality requirements within a fast-paced medical device manufacturing environment.

Key Responsibilities

Regulatory Compliance & Documentation

• Ensure documentation and processes comply with FDA QSR, ISO 13485, ISO 14971, and applicable global regulatory requirements.
• Create, review, and maintain regulatory documentation including Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), risk management files, and technical documentation.
• Support regulatory submissions, product registrations, renewals, and change assessments.
• Monitor regulatory intelligence and communicate new or updated regulatory requirements internally.
• Participate in product lifecycle change control processes to maintain regulatory compliance.
• Support product submissions to meet global regulatory requirements.
• Support compliance activities related to IEC 60601-1, IEC 60601-1-2 (EMC) and related standards.
• Coordinate product safety and EMC testing with external test laboratories and certification bodies (e.g., NRTL, CB Scheme).
• Review and interpret test reports to ensure alignment with risk management documentation and regulatory submissions.
• Support gap assessments and remediation activities related to electrical safety and EMC compliance.

Quality Engineering

• Lead and support investigations for nonconformances, complaints, and audit findings using formal root cause analysis tools.
• Participate in or lead Corrective and Preventive Action (CAPA) activities including root cause identification and effectiveness verification.
• Support process, equipment, and inspection method validations (IQ/OQ/PQ).
• Develop and maintain inspection plans and process control documentation for manufacturing operations.
• Analyze quality and process data to identify trends and drive continuous improvement initiatives.

Audits & Quality System Support

• Support internal audits, supplier audits, and regulatory inspections including FDA and notified body audits.
• Assist in maintaining audit readiness by ensuring documentation, records, and procedures meet regulatory requirements.
• Support internal training on quality system procedures and regulatory standards.

Cross-Functional Collaboration

• Provide regulatory and quality expertise for engineering projects, manufacturing improvements, and supplier activities.
• Partner with Purchasing and Supplier Quality on supplier evaluations, incoming inspection controls, and supplier corrective actions.
• Serve as a subject matter expert for interpreting regulatory and quality requirements across daily operations.

Qualifications

Re…