Quality Assurance Engineer

Job Summary

The Site Quality Assurance Engineer I supports manufacturing and operational quality activities, with a focus on investigations, quality data analysis, and process improvement. This role partners with Manufacturing, Operations, Supplier Quality, and Regulatory teams to support site quality processes and contribute to activities that ensure products meet regulatory requirements, company standards, and customer expectations.

Essential Functions

• Support investigations related to manufacturing and operational quality issues, including data gathering, documentation, and follow-up actions.
• Analyze manufacturing quality data to identify trends, recurring issues, and opportunities for process and product quality improvement.
• Assist in nonconforming material investigations and Material Review Board activities, including documentation, disposition support, and coordination with cross-functional teams.
• Support process validation and equipment qualification activities through review of documentation, participation in quality assessments, and support of related quality processes.
• Participate in manufacturing process improvement initiatives to enhance product quality, process consistency, and quality system effectiveness.
• Assist with supplier quality investigations and corrective action activities to support timely resolution of supplier-related quality issues.
• Support internal audits, inspection readiness, and regulatory compliance activities to help ensure adherence to applicable quality system requirements and internal procedures.
• Partner with Manufacturing, Operations, Engineering, Supplier Quality, and Regulatory teams to support resolution of site quality issues and implementation of effective solutions.
• Maintain clear, accurate, and timely documentation of investigations, analyses, and quality records.
• Contribute to continuous improvement initiatives related to manufacturing quality, process performance, and compliance.

Required/Preferred Education and Experience

• Bachelor's Degree in Engineering or a related technical discipline
• 2+ years of relevant experience in quality engineering, manufacturing engineering, or a related quality or operations role, preferably in a regulated industry
• Internship, co-op, or early career experience in medical devices, manufacturing, or a regulated industry
• Experience supporting supplier quality investigations or corrective action activities
• Experience using quality system tools or data analysis tools is a plus

Knowledge, Skills and Abilities

• Basic understanding of engineering principles, data analysis, and problem-solving techniques.
• Familiarity with root cause investigation tools and structured problem-solving methods.
• Strong organizational skills and attention to detail, with the ability to manage documentation and follow established processes.
• Strong written and verbal communication skills, with the ability to clearly document findings and communicate with technical stakeholders.
• Ability to work effectively in a remote environment while collaborating across teams and time zones.
• Familiarity with FDA Quality System requirements, ISO 13485, and medical device regulatory requirements.
• Exposure to nonconformance management, MRB processes, process validation, or equipment qualification activities.