Position Overview:

Our client, a rapidly growing medical device company specializing in catheter devices, is seeking a self-driven Quality Engineer to support their expanding operations. This is a key opportunity for an experienced professional to play a vital role in ensuring product quality and regulatory compliance as the company scales. The ideal candidate will bring at least 4 years of relevant industry experience and thrive in a fast-paced, collaborative environment.

Key Responsibilities:

• Ensure product quality and compliance with FDA (21 CFR 820), ISO 13485, and applicable regulatory standards.
• Lead root cause investigations and implement effective corrective and preventive actions (CAPA).
• Support validation activities (IQ/OQ/PQ) for equipment, processes, and product.
• Perform risk management activities including FMEA and risk assessments throughout the product lifecycle.
• Collaborate cross-functionally with R&D, Manufacturing, and Regulatory to support design transfer and process improvements.
• Review and approve design and process documentation including protocols, reports, and technical files.
• Conduct supplier quality management activities, including audits, SCARs, and performance monitoring.

Required Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• Minimum 4 years of quality engineering experience in the medical device industry.
• Hands-on experience with cardiovascular catheters, interventional devices, or Class II/III implantables strongly preferred.
• In-depth knowledge of quality systems, risk management, and validation.
• Self-directed, with the ability to work independently and manage multiple priorities.

Preferred Qualifications:

• Certified Quality Engineer (CQE) or similar certification.
• Experience with statistical analysis tools (e.g., Minitab).
• Working knowledge of EU MDR, ISO 14971, and IEC 60601.
• Experience in a small team/start-up environment.