Quality Assurance Engineer

Quality Assurance Engineer

About the Opportunity

We are seeking a Quality Assurance Engineer to join a growing medical device organization. This position plays a key role in maintaining and improving the Quality Management System (QMS), ensuring compliance with global regulatory requirements, and supporting product quality throughout the product lifecycle.

The successful candidate will work cross-functionally with Engineering, Regulatory Affairs, Operations, and Product Development teams to drive quality initiatives, manage quality system activities, and support continuous improvement efforts.

Key Responsibilities

• Ensure compliance with applicable medical device regulations and standards, including ISO 13485, MDR, MDSAP, and FDA Quality System requirements.
• Manage product complaint investigations, including intake, documentation, trending, follow-up activities, and closure.
• Support adverse event reporting activities, including preparation and submission of Medical Device Reports (MDRs) and other regulatory reports.
• Coordinate and facilitate CAPA activities, including root cause investigations, corrective actions, preventive actions, and effectiveness verification.
• Analyze quality system data and generate quality metrics and reports related to complaints, CAPAs, nonconformances, supplier performance, training, and document control.
• Participate in product development projects, providing quality and regulatory guidance throughout the development process.
• Support the creation, review, and maintenance of Quality Management System documentation.
• Review and approve controlled document changes in accordance with quality system requirements.
• Assist with field actions, recalls, and post-market quality activities as required.
• Support risk management activities, including FMEA development and risk assessments.
• Participate in internal audits, external audits, notified body audits, and regulatory inspections.
• Develop and deliver quality-related training across the organization.
• Provide quality support to regulatory and commercial activities, including distributor and customer documentation requests.
• Drive continuous improvement initiatives to strengthen product quality and regulatory compliance.

Qualifications

Education

• Bachelor's degree in Engineering, Science, or a related technical discipline.

Experience

• 2–3 years of Quality Assurance experience within a regulated industry, preferably medical devices.
• Experience working within ISO 13485 and/or MDR regulated environments.
• Experience with complaint handling, CAPA investigations, and quality system processes preferred.
• Familiarity with electronic Quality Management Systems (eQMS), such as MasterControl or similar platforms.
• Strong analytical skills with experience using Excel, including pivot tables and data analysis tools.

Preferred Background

Candidates with experience supporting Class II or Class III medical devices, post-market surveillance activities, audit participation, and risk management processes will be highly regarded.

Why Apply?

This is an excellent opportunity for an early-career Quality Engineer to gain broad exposure across Quality Systems, Regulatory Compliance, Product Development, Risk Management, CAPA, Complaint Handling, and Audit Support within a dynamic medical device environment.