PMS Quality Assurance Engineer

Description

Driven by strong growth and rapidly expanding business, our company is recruiting a Quality Assurance Engineer to support its development. We are seeking a highly motivated Quality Assurance Engineer to join our growing Post-Market Surveillance team. In this role, you will play a vital part in ensuring the safety and effectiveness of our medical devices after they have been launched on the market. You will be responsible for monitoring device performance, analyzing data, identifying potential risks, and reporting these findings to regulatory authorities and the company.

Job Responsibilities

• Develop and implement a comprehensive plan for post‑market surveillance activities, following regulatory requirements (MDR, MDSAP, FDA, etc.).
• Collect, review, and analyze post‑market data from various sources (customer complaint reports, regulatory agencies notifications, adverse event reports, clinical studies) to identify trends and potential safety issues.
• Perform risk analysis based on post‑market data and other relevant information to assess product risks and propose adequate updates to the applicable documentation.
• Perform Health Hazard Evaluations (HHEs) and Health Risk Assessments (HRAs) per internal procedures.
• Prepare reports summarizing findings and propose corrective actions, if necessary.
• Prepare post‑market surveillance mandatory reports per the applicable regulations and standards.
• Collaborate with cross‑functional teams (R&D, Quality Assurance) to understand device functionalities and potential failure modes.
• Stay up to date with regulatory guidelines and industry best practices for post‑market surveillance.
• Develop and maintain process procedures and work instructions as part of continuous improvement.
• Maintain a strong understanding of the medical devices and their clinical applications.

Qualification Requirements

• Master's degree in biomedical engineering, mechanical engineering, or related field (Bac+5).
• Minimum of 2 years of experience in post‑market surveillance, complaint handling, or related roles in the medical device industry.
• Strong understanding of regulatory requirements and standards governing medical devices, including Regulation (EU) 2017/745, MDSAP, FDA regulations, and ISO 13485.
• Experience with complaint investigation and root‑cause analysis methodologies (e.g., 5 Whys, fishbone diagram, FMEA).
• Fluent in English, with excellent written and verbal communication skills.
• Effective communication and interpersonal skills, with the ability to collaborate cross‑functionally and communicate findings and recommendations.
• Ability to work independently and manage multiple projects simultaneously in a fast‑paced environment.
• Experience with medical device risk management processes (e.g., ISO 14971) is preferred.
• Comfortable with Microsoft Office suite (e.g., Excel) and with any database software solutions.